Engineering Jobs in Hanscom Afb, MA

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At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today’s mission and stay ahead of tomorrow’s threat. Our team solves tough, meaningful problems that create a safer, more secure world. 

Manufacturing Engineers learn production operations and the manufacturing discipline in a controlled environment.  They develop manufacturing engineering skills alongside their team; internalize an understanding of safety, quality, delivery, and cost; and use Raytheon systems and tools to create innovative and unique solutions to today’s manufacturing challenges. Manufacturing Engineers build technical depth into manufacturing processes and are accountable for improvement and optimization.

Primary responsibilities include developing the comprehensive manufacturing process for 3D metal parts for various radar, integrated sensor, and effector programs. The candidate will create, test, and upgrade Coordinate Measuring Machine (CMM) programs, develop and document fixturing and setups for CMM inspection, and create inspection plans. They will also assess process failures, disposition non-conforming hardware, and create and execute robust Root Cause/Corrective Action plans to permanently solve problems. This position requires close cooperation with the Operations team and other engineering disciplines. The desired candidate will possess excellent communication skills and be capable of working in a dynamic team environment.

What You Will Do

• Translate engineering design requirements into formal manufacturing process documentation including CMM programming, inspection planning, finishing requirements, and assembly instructions

• Support process improvements using data analysis, application of best practices, engaging with production personnel, and implementing innovative solutions to improve process capability and decrease cost

• Design, control, and improve the manufacturing process through collaboration with a multi-disciplined team

• Self-manage workload to support existing production, perform non-recurring engineering work for new products, and drive improvement projects to completion.

• Communicate effectively with Engineering and Operations leaders in department to ensure schedule needs are met and where any barriers to progress exist.

• Perform process development on new product introductions with an accelerated time to market

• Support continuous improvement initiatives and document standard methodologies and standard work for CMM and manual inspection operations

• Review metrology and statistical process control (SPC) data to identify and address potential defects before they occur

• Troubleshoot manufacturing issues alongside Quality and Operations personnel and apply CORE/6-sigma methods to determine Root Cause and apply Corrective Actions

Qualifications You Must Have

• Typically requires a Bachelor's degree in Science, Technology, Engineering or Math (STEM) and a minimum 5 years of prior relevant experience. 

• Knowledge of CMM programming and workpiece holding and manual inspection methodology

• 5+ years correctly interpreting engineering drawings, including ASME Y14.5 Geometric Dimensions and Tolerances as well as typical government and industry specifications

• The ability to obtain and maintain a US security clearance. U.S. citizenship is required as only U.S. citizens are eligible for a security clearance

Qualifications We Prefer

• CMM programming experience for complex workpieces typically requiring 4+ axis machining centers

• Demonstrated working knowledge of Creo CAD Software

• Process familiarity with paint, plating, and structural assembly

• Results-oriented focus on past projects to evaluate success

• Demonstrated hands-on mechanical aptitude

• Strong organization skills with ability to manage multiple tasks simultaneously

• Ability to work individually to support team/department success

• Excellent written, verbal, visual, and graphical communication skills

• Possess excellent judgment and professional maturity

• Knowledge and ability to apply CORE principles and techniques

• Active DoD Security Clearance

What We Offer

• Our values drive our actions, behaviors, and performance with a vision for a safer, more connected world. At RTX we value: Safety, Trust, Respect, Accountability, Collaboration, and Innovation.

• Relocation assistance is not available

Learn More & Apply Now!

Please consider the following role type definition as you apply for this role.

• Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products.

As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote.

RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act.

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Date Posted:

Country:

Location:

Position Role Type:

U.S. Citizen, U.S. Person, or Immigration Status Requirements:

Security Clearance Type:

Security Clearance Status:

At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today’s mission and stay ahead of tomorrow’s threat. Our team solves tough, meaningful problems that create a safer, more secure world. 

Job Summary:

An exciting opportunity exists at Raytheon for a Semiconductor Dry Etch Engineering Lead to join our III-V compound semiconductor foundry team fabricating gallium nitride and gallium arsenide-based devices within the Advanced Microelectronics Solutions (AMS) Department.  This role requires a broad understanding of microelectronics processing and subject matter expertise in one or more dry etch related techniques including plasma ashing/descum, reactive ion etching (RIE), and inductively coupled etching (ICP).

As a member of the AMS Department, the individual in this role will serve as the dry etch processes lead engineer and collaborate with the various engineering work centers in the III-V semiconductor wafer foundry. The candidate will lead and assist projects in process sustainment, capital allocation, directing process and capital qualifications, improving cycle time, improving product yield, developing new data driven controls, and driving overall wafer movement efficiency.

The chosen candidate is expected to be an innovative and creative thinker capable of probing issues and reaching solutions both independently and in a team environment. The ideal candidate will have working knowledge of various microelectronics processing techniques beyond deposition, including wet and dry etching, lift-off techniques, photolithography, metrology, process characterization, foundry data integrity, and large data analysis methods.

The candidate is expected to work well in large and small, cross-functional teams, understand foundry processes, determine capacity limitations, improve overall equipment effectiveness, identify yield improvement opportunities, gather sponsorship and team resources, and execute on continuous improvement activities. Presence on the foundry floor is essential for quick resolution of technical issues as well as the ability to work with operations, facilities, equipment, and quality teams. The role requires a large degree of multitasking with attention to detail while managing priorities depending on the nature of the problems and the commitments.

This role will be 100% on-site and based in Andover, MA.

What You Will Do:

• Sustainment of current dry etch production processes and involvement with development of new process
• Set and report center priorities at the 8am foundry tier meeting
• Identify process improvement opportunities
• Lead 8Ds and RCCAs
• Create, document, maintain and approve work instructions
• Assist process engineers in training users and operators on semiconductor processes and equipment
• Manipulate large datasets and use statistical analysis to define SPC controls, manage projects, and assign risk
• Develop and report on actionable deposition work center health metrics
• Identify capital needs, collaborate with tool vendors, assist in tool acceptance, and create plans/schedules for tool and process qualifications
• Frequently work on the foundry floor and interact with various process engineering, equipment engineering, digital technologies, quality, facilities, and operation teams

Qualifications You Must Have:

• Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and a minimum of 8 years of prior relevant experience in semiconductor processing techniques including photolithography, dielectric deposition, metals evaporation, and optical or scanning electron microscope inspections
• The ability to obtain and maintain a US security clearance. U.S. citizenship is required as only U.S. citizens are eligible for a security clearance.

Qualifications We Prefer:

• Knowledge of dry etch tools, tool health monitoring, uniformity controls, SECS/GEM experience, and proficient in statistical process control
• Excellent communication skills to effectively transfer ideas
• Broad knowledge related to semiconductor processing, device physics, and data analysis
• Experience troubleshooting a wide range set of fabrication equipment in addition to establishing equipment qualification and preventative maintenance procedures
• Experience in a data analysis software packages (e.g. MATLAB, Python, SQL, JMP)
• Ability to lead and coordinate technical projects with cross-functional teams
• Experience with characterizing, understanding, and improving semiconductor device performance and reliability

What We Offer:

Our values drive our actions, behaviors, and performance with a vision for a safer, more connected world. At RTX we value: Trust, Respect, Accountability, Collaboration, and Innovation.

As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote.

RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act.

Privacy Policy and Terms:

Click on this link to read the Policy and Terms

Date Posted:

Country:

Location:

Position Role Type:

U.S. Citizen, U.S. Person, or Immigration Status Requirements:

Security Clearance Type:

Security Clearance Status:

At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. With over 100 years of experience, we bring renowned engineering expertise to stay ahead of tomorrow’s threats. Our team solves tough, meaningful problems that create a safer, more secure world.

Raytheon is seeking a Senior Software Engineer to join the National Advanced Surface-to-Air Missile System (NASAMS) team. NASAMS is a cutting-edge air defense system that protects critical assets and population centers from aerial threats by integrating advanced radar, command and control, and missile systems. This role is based in Tewksbury, Massachusetts, where you’ll work collaboratively to deliver high-quality software solutions that support the NASAMS system effectivity chain: Detect, Decide, Engage, and Destroy.

Leveraging Agile and DevSecOps principles, you’ll design, develop, test, and deploy software for mission-critical capabilities. As a senior member of the team, you will also mentor junior engineers, fostering a culture of technical excellence and collaboration.

What You Will Do

• Design, develop, and deliver real-time software for NASAMS, including Detect, Decide, Engage, and Destroy functionalities.

• Develop solutions for target acquisition, threat evaluation, missile firing, and other critical functions.

• Maintain and deploy complex software in an Agile/DevSecOps environment with secure, high-quality, high-frequency deliveries.

• Mentor junior engineers, promoting technical growth and collaboration.

• Participate in reviews of software components to ensure quality and alignment with program requirements.

• Contribute to testing frameworks and CI/CD practices to enable efficient software validation and delivery.

• Solve problems within defined scope and ensure seamless integration of software with NASAMS hardware and systems.

What You Will Learn

• The workings of the NASAMS system, including integration with advanced radar and C2 systems.

• How to design and maintain software for complex, real-time systems supporting mission-critical functions.

• Leadership skills to coordinate and contribute to multi-disciplinary teams.

• Best practices for software testing and deployment in a DevSecOps environment.

• How to collaborate in a fast-paced, Agile environment delivering secure, high-frequency updates.

Key Contributions to NASAMS - as part of the NASAMS program, you will contribute to the following areas:

• Detect: Develop solutions for target acquisition, integrated IFF, and tracking updates.

• Decide: Implement Single Integrated Air Picture, threat evaluation, launcher assignment, and multi-missile handling.

• Engage: Create algorithms for azimuth slew, targeting data transfer, missile firing, and mission abort.

• Destroy: Support motor ignition, inertial guidance, seeker search, target lock-on, and terminal guidance.

Qualifications You Must Have

• Typically requires a Bachelor's of Science Degree in Science, Technology, Engineering or Mathematics (STEM) and a minimum of 5 years of prior relevant experience.

• Experience in programming languages (e.g., C++, Java).

• Experience with Agile and DevSecOps methodologies and tools (e.g., CI/CD pipelines, Docker, Jenkins).

• Experience leading teams and resolving complex technical challenges.

• Ability to obtain U.S. government issued Secret security clearance is required after start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance.

Qualifications We Prefer

• Strong problem-solving and communication skills.

• Extensive experience with radar software development and/or radar concepts.

• Familiarity with missile defense programs and large, complex systems.

• Hands-on experience with tools such as the Atlassian Suite (e.g., Bitbucket, Artifactory, JIRA, Confluence), Jenkins, Eclipse, and Ansible.

• Strong knowledge of Linux Operating Systems, particularly Red Hat Enterprise Linux.

• Familiarity with CI/CD environments and pipelines, including experience with DevSecOps methodologies.

• Advanced knowledge of software integration, testing frameworks, and debugging tools.

• Ability to succeed in a fast-paced, dynamic environment with time-critical requirements.

• Proven experience contributing to a team environment and developing creative solutions.

• Demonstrated ability to promote a culture of continuous learning and collaboration.

What We Offer

• Our values drive our actions, behaviors, and performance with a vision for a safer, more connected world. At RTX we value: Safety, Trust, Respect, Accountability, Collaboration, and Innovation.

• Relocation Eligible.

Learn More & Apply Now!

Please consider the following role type definition as you apply for this role. Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products.

This position requires a security clearance. DCSA Consolidated Adjudication Services (DCSA CAS), an agency of the Department of Defense, handles and adjudicates the security clearance process. More information about Security Clearances can be found on the US Department of State government website here:  

As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote.

RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act.

Privacy Policy and Terms:

Click on this link to read the Policy and Terms

Date Posted:

Country:

Location:

Position Role Type:

U.S. Citizen, U.S. Person, or Immigration Status Requirements:

Security Clearance Type:

Security Clearance Status:

At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today's mission and stay ahead of tomorrow's threat. Our team solves tough, meaningful problems that create a safer, more secure world.

Raytheon is seeking a highly motivated and experienced Chief Product Owner (CPO) to lead the Radar Digital Product Line (RDPL) SPY-6 Enterprise Air Surveillance Radar (EASR) effort. This critical role involves providing strategic technical and programmatic oversight for the SPY-6(V)2 and SPY-6(V)3 radar configurations, supporting program execution, and driving alignment with broader RDPL objectives. The Chief Product Owner will play a key role in delivering high-quality radar systems to the U.S. Navy and contributing to the growth and success of RDPL.

What You Will Do

• Serve as the technical and programmatic leader for the SPY-6 EASR effort within the product line, overseeing the development, integration, and delivery of SPY-6(V)2 and SPY-6(V)3 radar configurations.
• Manage technical baselines and ensure alignment across multiple shipsets and platforms to meet customer requirements.
• Coordinate with SPY-6(V)1 teams to manage dependencies, mitigate risks, and ensure seamless integration across the SPY-6 radar family.
• Lead a matrixed engineering team, fostering collaboration across disciplines to meet program objectives and exceed customer expectations.
• Drive the execution of RDPL's productivity and velocity goals through innovative engineering and process improvements.
• Act as the primary interface with internal stakeholders and external customers, ensuring alignment of technical execution with programmatic goals.
• Influence customer perceptions and maintain strong relationships with key stakeholders.
• Support risk management, schedule adherence, and cost control to meet program deliverables and financial objectives.

Qualifications You Must Have

• Typically requires a Bachelor's in Science, Technology, Engineering, or Mathematics (STEM) and a minimum of 10 years of prior engineering experience.
• Experience in managing multidisciplinary engineering teams.
• Experience managing technical baselines and delivering mission-critical systems to customers.
• Active and transferable U.S. government issued Secret security clearance is required prior to start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance.

Qualifications We Prefer

• Experience with U.S. Navy radar systems and understanding of mission-critical requirements.
• Experience with Raytheon's RDPL objectives and processes, including productivity and velocity improvement initiatives.
• Excellent communication, negotiation, and stakeholder management skills.
• Strong technical background in radar systems.

What We Offer

• Our values drive our actions, behaviors, and performance with a vision for a safer, more connected world. At RTX we value: Safety, Trust, Respect, Accountability, Collaboration, and Innovation.
• Relocation eligible.

Learn More & Apply Now!

Please consider the following role type definition as you apply for this role.

Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products.

This position requires a security clearance. DCSA Consolidated Adjudication Services (DCSA , an agency of the Department of Defense, handles and adjudicates the security clearance process. More information about Security Clearances can be found on the US Department of State government website here:

As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote.

RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act.

Privacy Policy and Terms:

Click on this link to read the Policy and Terms

OPT Industries ( ) is a venture-backed MIT spinoff company that is focused on building the next generation of additive manufacturing technology. Working at the intersection of automation engineering, computational design, and polymer science, we design and commercially manufacture highly customizable materials and products – everything from electrical components to luxury fashion.

Position Summary: Own and improve the reliability of production equipment by troubleshooting and sustaining electromechanical, controls, and firmware-adjacent systems across OPT’s manufacturing floor.

Key Responsibilities:

• Own and develop Python-based control, test, and automation systems.
• Debug and extend ATMega embedded C/C++ (incl. hardware-software interfaces, IP networks)
• Build and maintain hardware-software interfaces for sensors, motors, actuators, and data acquisition systems.
• Design test infrastructure, logging, and fault detection to support production uptime and repeatability.
• Update equipment, documentation, training, and maintenance procedures to prevent recurrence
• Support troubleshooting and urgent production issues on aggressive timelines

Qualifications:

• 5+ years of relevant experience, or 3+ years plus a Master’s degree in robotics, mechatronics, EE, CS, or a related field.
• Strong Python background with experience in hardware control, automation, or test systems.
• Hands-on experience with electromechanical systems: motors, encoders, sensors, power electronics, and control loops.
• Working knowledge of embedded C for microcontroller-based systems
• Comfortable using Bash / Linux environments for scripting, debugging, and system operations.
• Experience supporting systems in a production or manufacturing environment is a strong plus.

OPT Industries is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

As a Director of AI-enabled Quality Systems, you will own the day-to-day execution and continuous improvement of SiPhox’s Quality Management System (QMS), supporting the development, validation, and production of regulated products from early prototypes through clinical and manufacturing stages. This is a hands-on, high-impact role in a fast-moving, multidisciplinary environment where quality must keep pace with innovation.

You will work closely with engineering, operations, and clinical teams to ensure that products, processes, and documentation meet internal requirements and applicable regulatory standards. Your focus will be on practical quality execution, ensuring verification and validation (V&V), design controls, and production systems are implemented effectively, issues are resolved efficiently, and results can be trusted.

In this role, you will serve as both a quality gatekeeper and a collaborative partner, helping teams build compliant processes without slowing progress. You will also play a key role in strengthening and scaling the QMS as the company grows, identifying opportunities to improve efficiency, clarity, and robustness across development and operations.

This role will have a high impact on SiPhox’s success, with significant potential for career development and growth as the company progresses through FDA submissions, manufacturing ramp up, and product launch.

Responsibilities

Quality System Leadership

• Serve as a senior owner and architect of the ISO 13485 Quality Management System (QMS), ensuring scalability, inspection readiness, and alignment with FDA (21 CFR 820 / QMSR), EU IVDR (if applicable), and other global requirements.
• Lead strategic evolution of document and record control processes, ensuring robust change control, traceability, and configuration management across design and manufacturing.
• Drive quality system maturity, ensuring processes are right-sized for a high-growth, fast-paced medical device environment.

Design Controls & Product Development

• Lead and oversee design control activities in accordance with 21 CFR 820.30 and ISO 13485, ensuring clear traceability from user needs through verification, validation, and risk management.
• Partner with engineering, assay development, software, and operations teams to embed quality into product development from concept through commercialization.
• Ensure Design History Files (DHFs), Device Master Records (DMRs), and technical documentation are complete, audit-ready, and submission-ready.

Regulatory Submission Support

• Lead quality strategy and documentation support for FDA submissions (510(k), De Novo, etc.), including substantial involvement in at least one cleared IVD submission.
• Ensure verification & validation documentation, risk files, and QMS elements meet regulatory expectations.
• Support responses to FDA questions, deficiency letters, and inspection observations.

CAPA & Continuous Improvement

• Own and elevate the CAPA system, ensuring robust investigations, root cause analysis (e.g., 5-Why, Fishbone, FMEA), and effective corrective actions.
• Analyze quality data trends to identify systemic risks and drive proactive improvement.
• Mentor cross-functional teams in structured problem-solving methodologies.

Risk Management

• Lead risk management activities in accordance with ISO 14971.
• Ensure risk controls are appropriately linked to design inputs, verification/validation, production controls, and post-market activities.
• Drive integration of risk management throughout the product lifecycle.

Audit & Inspection Readiness

• Lead internal audit programs and supplier quality audits.
• Serve as a primary quality representative during ISO 13485 audits and FDA inspections.
• Drive timely and effective responses to audit findings and regulatory observations.

Post-Market & Compliance

• Oversee complaint handling, adverse event reporting (e.g., MDR), and post-market surveillance processes.
• Ensure effective feedback loops between post-market data and design/process improvements.

Training & Culture

• Architect and maintain a scalable, role-based training system with measurable effectiveness.
• Promote a strong culture of quality, ownership, and compliance across the organization.

Required Qualifications

• 8+ years of experience in medical device quality within an ISO 13485 environment.
• 5+ years of experience in IVD development and/or manufacturing.
• Direct participation in one or more successful FDA 510(k) submissions for an IVD device.
• Deep working knowledge of:
• ISO 13485
• 21 CFR 820 (and QMSR transition awareness)
• ISO 14971
• Design controls for IVD systems (including assay and/or instrument development)
• Demonstrated experience leading CAPA investigations and cross-functional quality initiatives.
• Experience serving as a key quality representative during external audits or inspections.
• Bachelor’s degree in engineering, life sciences, or related field (advanced degree preferred).
• Authorized to work in the U.S. without sponsorship.

Highly Desirable Experience

• Experience with combination systems (instrument + consumable IVD).
• Experience in CLIA-regulated laboratory environments.
• Experience with software quality (IEC 62304 familiarity).
• Experience building or significantly scaling a QMS in a startup environment.
• Experience supporting international submissions (CE marking under IVDR).

Additional notes

SiPhox Health is creating an entirely new category of at-home technology that brings advanced biological measurement into everyday life. Our platform brings together silicon photonics, microfluidics, motion systems, sensing, thermal control, and embedded computing inside a compact device that performs complex biochemical analysis in minutes. We are building a consumer product that has never existed before. It integrates optics, chemistry, mechanics, biology and electronics into a seamless experience designed for millions of homes.

We offer competitive benefits, including a Life Time Fitness membership and the opportunity to work in a fast-paced, mission-driven environment building the future of home health.

About the Role

Join our dynamic R&D team as a Quality Control Inspector. In this role, you’ll play a critical role in ensuring that our Pulse IVL System product meets established quality standards and specifications at various points in the organization while advocating for strict adherence to compliance practices within the facility.

Key Responsibilities

• With minimal supervision, performs incoming, in-process, and final inspections of components and finished device.
• Interprets quality inspection documents and deciphers quality expectations for the product.
• Approves products by confirming specifications, conducting visual and measurement tests, returning products for re-work and confirming re-work
• Monitors use of equipment to ensure it is calibrated before use; keeps measurement equipment operating accurately
• Performs and documents results of inspections per company procedures.
• Responsible for initiating non-conformance reports and ensuring non-conforming material is processed in accordance with the disposition. May assist with nonconformance investigations as needed.
• Review and verify documentation for compliance with specifications and regulatory requirements (e.g., FDA, ISO 13485).
• Maintain accurate inspection records and support traceability and documentation control.
• Collaborate with engineering and manufacturing teams to identify and resolve quality issues.
• Assist in root cause analysis and corrective/preventive actions (CAPA).
• Support internal audits and regulatory inspections.
• Ensure calibration and maintenance of inspection tools and equipment.

Required Qualifications

• Associate or bachelor’s degree in business, supply chain, life sciences or other scientific field or equivalent work experience (3-5 years).
• 3+ years of experience in quality inspection in the medical device industry.
• Strong understanding of quality systems and regulatory standards (ISO 13485, FDA 21 CFR Part 820).
• Proficiency in using inspection tools (calipers, micrometers, gauges, vision systems) and reading technical drawings/specifications.
• Excellent attention to detail and documentation skills.
• Ability to work independently and as part of a cross-functional team.
• Strong communication and problem-solving skills.
• Experience with electronic documentation systems (e.g., eQMS).
• Familiarity with cleanroom protocols and GMP practices.
• ASQ certification (e.g., CQI) is a plus.
• Two (2) or more years of laboratory experience
• Experience in QC inspection, cleanroom manufacturing, and medical device start-up
• 3+ year of Quality Control Experience in Medical Device Manufacturing. Knowledge of clean room operations
• Understanding of a quality management system (QMS) and cGMP knowledge
• Proficient level with Microsoft Office (Outlook, Excel, PowerPoint, and Word)
• Knowledge of Non-Conformance Reports (NCRs)

Immediate need for a talented USA-Systems Engineer III (IT). This is a 08+ Months Contract opportunity with long-term potential and is located in Waltham, MA (Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID:26-06360

Pay Range: $60 - $85/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Design, develop, deploy, and operate production‑grade AI/ML systems and data pipelines in an agile environment.
• Build, maintain, and optimize CI/CD pipelines using GitHub Actions to enable automated testing and deployment.
• Deploy and operate applications on Kubernetes using GitOps practices (e.g., ArgoCD).
• Develop user‑facing applications through APIs and/or graphical interfaces.
• Deploy predictive models into production environments with a strong focus on reliability, scalability, and observability.
• Build and optimize compute pipelines supporting data processing and model training.
• Collaborate closely with data scientists, computational biologists, and vaccine researchers to translate scientific needs into robust digital solutions.
• Actively participate in agile ceremonies and contribute to continuous improvement of team practices.
• Ensure high standards for code quality, documentation, and knowledge transfer.
• Communicate complex technical concepts clearly to both technical and non‑technical stakeholders.

Key Requirements and Technology Experience:

• Skills-Experience in agile environments, with proven experience deploying and operating applications in production, and Python programming skills
• Experience with GitHub Actions and CI/CD pipeline implementation, Kubernetes-based container orchestration, and GitOps practices (ArgoCD or equivalent). DevOps, automation
• Experience in Production deployment of machine‑learning models and MLOps practices, API and/or web application development, and familiarity with major cloud platforms (AWS, Azure, or GCP)
• Bachelor’s degree or higher in Computer Science, Software Engineering, Data Science, or a related field. Advanced degrees are valued but not required.
• Minimum of 5 years of professional software engineering experience.
• Demonstrated delivery of production‑level systems with measurable impact.
• Strong experience working in agile environments with a customer‑oriented mindset.
• Proven experience deploying and operating applications in production.
• Technical Skills:
• GitHub Actions and CI/CD pipeline implementation.
• Kubernetes‑based container orchestration.
• Git Ops practices (Argo CD or equivalent).
• Strong Python programming skills.
• API and/or web application development.
• Production deployment of machine‑learning models and ML Ops practices.
• Familiarity with major cloud platforms (AWS, Azure, or GCP).
• English: fluent (mandatory). French: nice to have.
• Experience in pharmaceutical, biotechnology, or life‑sciences environments.
• Awareness of drug discovery, vaccine development, or experimental sciences.
• Experience with workflow orchestration tools such as Meta flow.
• Experience in mentoring or technical training.
• Contributions to open‑source or technical communities.
• Experience designing scalable data engineering solutions.
• Manager's Note:-Hybrid working model with a minimum of three days per week on site in Waltham, MA.
• Agile and fast-paced team environment focused on rapid iteration and delivery.
• Strong cross‑functional collaboration across Vaccines R&D, Digital, and CMC.
• Open to candidates willing to relocate at their own expense
• Free parking site
• Possibility of extension, with a gap in work at the end of year (Nov/ Dec) and restart work in January
• English: fluent (mandatory)
• Primary Manager sits in France, local team will be present in EU and US
• Team is building a system of predictive models
• Software Engineer, previous experience moving models in to prediction

Our client is a leading Healthcare Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role

The Research Associate/Quality Engineer will be responsible for performing mechanical testing of materials and components using instruments such as Mecmesin, Instron, or equivalent force-measurement systems. This role will support tensile, compression, shear, puncture, and force displacement characterization to ensure product performance, robustness, and compliance with internal quality standards. In addition, the individual will contribute to method development, qualification activities, and routine QC release testing to support clinical and commercial manufacturing programs. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Key Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

• Perform mechanical testing of materials, components, and finished MAP products using Mecmesin, Instron, or comparable systems, including tensile, compression, shear, puncture, and force displacement profiling.
• Develop, optimize, and maintain mechanical test methods to support product characterization, comparability studies, and design verification/validation activities.
• Execute routine QC mechanical release testing aligned with cGMP expectations and data integrity standards.
• Troubleshoot mechanical testing issues, support instrumentation maintenance, and ensure proper calibration and documentation
• Analyze mechanical test data, prepare technical reports, and document all activities in audit-ready laboratory records.
• Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success.
• Assist in broader QC testing efforts as needed, including support for analytical, functional, and stability assays.
• Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
• Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
• Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases.
• Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Materials Science, Biomedical Engineering, or a related discipline; 1–3 years of relevant mechanical testing or QC experience, or a master’s degree with applicable laboratory experience.
• Hands-on experience with mechanical testing instruments such as Mecmesin, Instron, Texture Analyzer, or equivalent force-measurement systems.
• Demonstrated proficiency in tensile, compression, shear, puncture, and force–displacement mechanical characterization.
• Experience developing, optimizing, and/or qualifying mechanical test methods for materials, components, or finished products.
• Familiarity with GMP, GLP, or ISO 17025 laboratory environments and strong understanding of data integrity (ALCOA+).
• Ability to analyze mechanical test data, generate clear technical reports, and maintain accurate documentation.
• Experience supporting QC release testing, method qualification, method transfer, or equipment qualification is a plus.
• Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment.
• Excellent verbal and written communication skills and comfort working within interdisciplinary teams.
• Commitment to collaborative work within interdisciplinary project teams.

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to  

Location: Woburn, MA (on-site 5 days per week)

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role:

The Quality Engineer I / II will support Quality Assurance activities for Vaxess’ combination product programs, with a strong focus on medical device design controls, risk management, and cGMP compliance. This role provides hands-on quality support across design and development, supplier oversight, process validation readiness, and batch record/data review, aligned with ISO 13485, 21 CFR 820, and applicable combination product regulations (21 CFR 4).

Reporting to the Quality Assurance Manager, this role works cross-functionally with Manufacturing, Process Development, Quality Control, and Material Management to support compliant execution and ensure product quality and safety during early clinical development.

Responsibilities:

• Support quality oversight of Vaxess combination product(s) to ensure compliance with safety, efficacy, and regulatory requirements.
• Administer and support the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, 21 CFR Part 4 (Combination Products), and applicable FDA and international regulations.
• Provide quality support for Design Control activities, including Design History File (DHF) maintenance, design reviews, Design Verification and Validation (DVV), and design changes.
• Support risk management activities, including development and maintenance of risk analyses (e.g., FMEA, hazard analyses) and linkage to design and process controls.
• Support process validation and qualification activities, including test method validation (TMV), process validation (PV), and equipment qualification, as applicable to Phase I and GMP-ready manufacturing.
• Participate in Material Review Board (MRB) activities, including nonconformance assessment, disposition, and documentation.
• Perform quality review and approval of batch records, executed manufacturing records, analytical data collection forms, test records, and technical or experimental reports.
• Collaborate in supplier quality management activities, including supplier qualification, auditing, monitoring, change evaluation, and periodic requalification.
• Author, review, and revise quality documentation, including SOPs, work instructions, test methods, protocols, reports, forms, and specifications.
• Support preparation, review, and organization of quality data and documentation for regulatory submissions and inspections.
• Contribute to continuous improvement initiatives within the QMS, including CAPA, deviation investigations, and quality metrics.

Qualifications:

• Quality Engineer I: Minimum of 3 years of experience in Quality Assurance or Quality Engineering within a cGMP-regulated medical device or combination product environment.
• Quality Engineer II: Typically 4–5 years of progressive quality experience in medical devices, pharmaceuticals, biologics, or combination products.
• Working knowledge of ISO 13485 and FDA medical device Quality System Regulations (21 CFR 820); familiarity with combination product requirements strongly preferred.
• Experience supporting early-phase (preclinical to Phase I) product development is highly desirable.
• Experience with design controls, risk management (FMEA), and validation activities preferred.
• Experience reviewing GMP documentation such as batch records, test methods, protocols, and reports.
• Strong written and verbal communication skills, with the ability to clearly document technical and quality concepts.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to