Engineering Jobs in Reading, 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. 

The Air Defense Ground Equipment (ADGE) Department leads mechanical design, development, and integration of platform systems. This includes shelter systems, hardware integration, cable & interconnections, as well as facility development, and site integration. The department is comprised of individuals with technical expertise and experience in hardware design, integration, and production support. 

The ADGE department is looking for a full-time Sr. Principal Mechanical Engineer to support Patriot Missile Change Control Board (CCB) for major components and sub-assemblies, including obsolescence upgrades, procurement and supplier support

What You Will Do

• Responsibilities (Core & Day to Day) Support design specification development through production qualification reviews and release including ensuring design is manufacturable
• Participate in design peer reviews and conduct trade studies to promote sound technical decisions.
• Provide responses to supplier questions related to general design expectations and interpretation of the relevant specifications​.
• Provide guidance on Raytheon expectations for design rigor, level of TDP & MDP documentation required, typical analysis approach, and other similar topics.
• Connect suppliers with Raytheon subject matter experts as required.
• Collaborate with other engineering disciplines, non-technical disciplines, and suppliers to develop robust design solutions and resolve technical challenges.
• Work with limited supervision and meet technical, schedule, and monetary commitments.
• Apply knowledge and experience in technical problem solving and hardware development in an engaged team environment.
• Drawing generation, drawing release, and drawing change incorporation

Qualifications You Must Have

• Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and a minimum of 10 years of prior relevant experience unless prohibited by local laws/regulation. Or An Advanced Degree in a related field and minimum 7 years experience
• Experience with ERB/CCB process; CCB chair certification or ability to be certified.
• Experience with solid modeling, creating and documenting mechanical designs in Pro/Engineer/CREO or similar modeling tools.
• Experience working within small electromechanical or gyroscope similar assembly/products.
• Experience with Geometric Dimensioning and Tolerancing (GD&T) and ASME drawing and documentation standards and procedures

Qualifications We Prefer

• Experience with materials, load bearing structures, shock/vibration/load analysis
• Experience using Computer Aided Design (CAD) tools
• Missile portfolio including reviewing trade studies, identification of suitable alternate and interchangeable materials, or design changes as needed
• Ensure technical integrity and engineering execution across the IPTs and other functions to meet cost, schedule, and technical requirements

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 Eligibility

Learn More & Apply Now!

• 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 for a Sr. Principal RF Module Design/Development Engineer to join our Module Development Section with the Advanced Microelectronics Solutions (AMS) Department as a technical lead. The AMS department designs, fabricates, and tests state-of-the-art Monolithic Microwave Integrated Circuits (MMICs) in our on-site foundry. These chips are designed into custom modules to support multiple programs and enhance the capabilities of next generation radar systems.

The successful candidate will be responsible for leading the technical design and development of RF/microwave modules containing GaAs- and GaN-based monolithic microwave integrated circuit (MMIC) products. This would be in active support of existing technologies in production as well as next generation products in development. This position requires a strong academic background and experience in RF/Microwave Design, Development, Integration & Test.

What You Will Do:

• Designing RF structures and transitions on multi-layer, multi-channel RF Modules and analog circuitry enabling both receive and transmit behavior

• Consulting across RF module design, MMIC design and assembly teams

• Troubleshooting RF Modules that are prototyped and under development

Qualifications You Must Have:

• Typically requires a Bachelor’s Degree in a Science, Technology, Engineering & Math (STEM) Field and Ten (10) or more years of relevant experience (An advanced STEM degree could count for 3 years of experience) with Microwave/RF module, subsystem and component analysis, design, and test

• 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:

• A Master’s degree or PhD. in a Science, Technology, Engineering & Math (STEM) Field 

• Experience leading teams and/or projects

• Experience in module/sub-system assembly & packaging process

• Experience in thermal modeling and analysis.

• Experience of different topology trade-offs, process and active/passive component selection, system/sub-system level, gain-loss analysis and flowing down requirements from the system to the component level

• Hands-on experience with electromagnetic simulation tools such as HFSS, ADS, CST.

• Layout experience in Mentor Graphics’ Xpedition, Cadence Virtuoso or AutoCAD

• Experience with analytical tools such as Matlab, Python, or JMP

• Experience in cost estimating, budget and schedule management

• Understanding of allocating and flowing down requirements from the system to the component level

• Experience in a production environment

• Experience with microwave testing techniques, including using spectrum analyzers, Real-time Spectrum Analyzers (RSAs), Vector Network Analyzers (VNAs) and Performance Network Analyzer (PNAs)

• Experience with GaAs and/or GaN MMIC devices       

• Current DoD Secret level 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: 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.

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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. 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

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.

Senior Validation Engineer

Site & Equipment Qualification

Radiopharmaceutical Manufacturing

Location: Wilmington, MA

Must have Green Card or Citizenship

Join my client’s cutting-edge radiopharmaceutical manufacturing operation and play a pivotal role in bringing life-changing therapies to patients. As the Senior Validation Engineer, you’ll lead site startup, facility qualification, and GMP equipment validation in a highly specialized, radiation-controlled environment. This is your opportunity to shape compliant, inspection-ready systems from the ground up in a rapidly advancing sector of biotech.

Why You Should Apply

• High-impact role supporting innovative radiopharmaceutical production
• Lead site startup and expansion initiatives in a regulated GMP setting
• Work with advanced systems: hot cells, isolators, synthesis modules
• Competitive salary range: $120,000 – $185,000 Depending on level and experience
• Comprehensive benefits package including medical, 401(k), and PTO

What You’ll Be Doing

• Lead facility, utility, and cleanroom (ISO) qualification activities
• Develop and execute Validation Master Plans (VMP)
• Author and execute URS, DQ, IQ, OQ, PQ protocols
• Oversee qualification of HVAC, WFI, clean steam, gases, and water systems
• Support FAT/SAT, manage deviations, CAPAs, and change controls
• Serve as SME during FDA and regulatory inspections

About You

• Bachelor’s degree in Engineering or related technical field
• Strong expertise in GMP commissioning & qualification lifecycle (ASTM E2500 preferred)
• Hands-on experience in aseptic manufacturing environments
• Experience with radiopharma systems (hot cells, shielded isolators, synthesis modules)
• Deep knowledge of 21 CFR 210/211 and radiation safety regulations

How To Apply

We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to and tell me why you’re interested. Or, feel free to email your resume. Please include Job#19738.

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

We are supporting the launch of a new robotics and automation engineering hub for a well-established global industrial technology company with approximately $400M in annual revenue.

This facility will serve as a center of excellence, combining office space with a hands-on production and integration environment for the design, assembly, and implementation of advanced robotic solutions.

This is a hands-on role responsible for overseeing day-to-day operational, facilities, and production support activities to ensure efficient and safe execution across the site.

Responsibilities:

Inventory & Supply Chain Management

• Receive and inspect incoming parts and materials for accuracy and quality
• Maintain inventory records and perform regular stock audits
• Coordinate with suppliers to resolve discrepancies and ensure timely fulfillment
• Track shipments and monitor delivery schedules

Production Coordination

• Schedule and coordinate work with assembly contractors and external vendors
• Ensure proper documentation and build instructions are provided
• Monitor production timelines and address issues that may impact delivery
• Support quality checks during and after assembly

Plant Safety & Compliance

• Implement and maintain workplace safety procedures in accordance with regulations
• Conduct routine safety inspections and address potential hazards
• Maintain safety records and documentation
• Provide safety guidance and training for employees and contractors

Facilities Management

• Oversee day-to-day maintenance of the engineering and production facility
• Coordinate minor repairs, equipment upkeep, and workspace organization
• Ensure the facility remains clean, safe, and optimized for efficient operations
• Manage external vendors for major repairs, maintenance, or upgrades

Purchasing & Vendor Management

• Source and procure parts, materials, tools, and equipment
• Obtain and compare quotes, negotiate pricing, and manage supplier relationships
• Track purchases and maintain expense records
• Maintain a database of approved suppliers and contractors

Operational & Administrative Support

• Maintain operational documentation related to inventory, production, and facilities
• Prepare reports on operational performance and recommend improvements
• Track budgets related to supplies, contractors, and facility needs
• Support onboarding and coordination of contractors or new team members

Cross-Functional Collaboration

• Partner closely with engineering, logistics, and leadership teams to support program execution
• Provide regular status updates and escalate operational risks or issues

Process Improvement

• Identify workflow inefficiencies and implement operational improvements
• Proactively resolve issues to minimize delays and disruptions

Qualifications

• Experience in operations, facilities, manufacturing, or production environments
• Strong organizational, multitasking, and problem-solving skills
• Knowledge of inventory management and supply chain processes
• Familiarity with manufacturing, assembly, or hardware environments
• Understanding of workplace safety standards and compliance
• Proficiency with tools or software for inventory tracking, scheduling, and reporting
• Strong communication skills and ability to work cross-functionally
• Hands-on, self-starter mindset comfortable in a fast-paced environment

About the Opportunity

• New robotics engineering hub located north of Boston with modern office and production lab space
• Opportunity to help build and scale operations from the ground up
• Backed by a stable, globally recognized industrial technology organization
• Strong growth plans and long-term career development potential