Engineering Jobs in Somerville, MA

• Serve as the technical project leader for NPI manufacturing activities, driving the development and commercialization of products.
• Provide strategic oversight of manufacturing readiness for new product introductions, ensuring alignment of engineering resources, project schedules, and cross-functional deliverables.
• Lead cross-functional collaboration with Product Development, Quality, Regulatory, Supply Chain, and Manufacturing Operations to ensure robust, scalable, and compliant processes.
• Coordinate, identify, and implement advanced manufacturing processes to ensure production capacity, efficiency, cost-effectiveness, and adherence to quality standards.
• Define project plans, timelines, and resources needed to support NPI manufacturing programs, ensuring accountability for milestones and deliverables.
• Apply in-depth technical expertise to specify, design, and validate equipment, tooling, fixtures, and automation used in production.
• Drive PFMEA, DFM/DFA, and design transfer activities to establish capable, efficient, and risk-mitigated manufacturing processes.
• Develop manufacturing assembly and test methods that ensure Critical to Quality (CTQ) and Critical to Assembly (CTA) requirements are met.
• Establish and track Key Performance Indicators (KPIs) and process capability metrics using statistical tools such as MSA, GR&R, and SPC.
• Represent externally and internally as a manufacturing subject matter expert (SME), ensuring effective knowledge transfer to production and suppliers.
• Mentor and guide junior engineers and technical staff, fostering a culture of engineering rigor, accountability, and innovation.
• Perform other tasks and duties as assigned/required.
  
  

• BS in Mechanical Engineering or related engineering discipline required.
• 10+ years of experience in an FDA/ISO-regulated medical device or medical equipment manufacturing environment.
• Are you ready to take the next step in a career that’s both challenging and deeply rewarding? If you have a background with
• Proven leadership in the selection, qualification, and scale-up of capital assembly equipment and automation.
  
  

• Advanced degree preferred.
• Demonstrated expertise in automated assembly methods, robotics, automated inspection, and fixture/tooling design.
• Strong knowledge of injection molding and plastic joining techniques (ultrasonic/RF/laser welding, adhesive/solvent bonding).
• Proficiency in SolidWorks for 3D modeling and design of assembly models, fixtures, and tooling.
• Lean Six Sigma experience and proficiency in statistical data analysis tools (Minitab or equivalent) strongly preferred.
• Strong project management skills, with demonstrated accountability for planning, execution, and delivery of NPI milestones.
• Exceptional leadership and interpersonal skills, with ability to influence and align cross-functional teams.
• Excellent verbal and written communication skills, with the ability to present technical and project information to leadership and stakeholders.
• Proven ability to thrive in a fast-paced, dynamic environment, with adaptability to shifting priorities.
• Ability to work independently with high competency, while also driving and coordinating team-based execution.
  
  

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
• Dental
• Vision
• Healthcare Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short Term Disability
• Long Term Disability
• 401K Plan
• Pet insurance
• Employee Stock Purchase Plan
  
  

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.

Hexagon Multivista is seeking a driven Account Executive with a hunter mentality to sell innovative digital workflow and geospatial solutions to AECO businesses. These companies typically generate $50 million to $1 billion in annual revenue and employ between 100 and 2,000 staff.

As part of Hexagon, you will play a critical role in generating new business, managing client relationships, and supporting client success across dynamic construction and technology markets.

Key Responsibilities

• New Business Acquisition:
• Prospect, qualify, and close new (net-new logo) accounts within the market segment.
• Sales Pipeline Management:
• Build and maintain a robust pipeline of potential and active clients to meet or exceed sales quotas.
• Client Relationship Management:
• Develop, grow, and maintain strong relationships with key client stakeholders, acting as a trusted advisor.
• Sales Cycle Management:
• Drive deals through the entire sales cycle, from initial outreach to negotiation and close.
• Product Demonstration:
• Effectively communicate product value, demonstrate workflows and solutions to potential clients, and tailor presentations to business outcomes.
• Cross-Functional Collaboration:
• Work with sales development, product, engineering, consulting, and customer success teams to deliver value and ensure customer satisfaction.
• Customer Feedback:
• Serve as the voice of the customer—gather and share feedback to drive product and service improvements.
• Reporting & Forecasting:
• Accurately track, forecast, and report sales pipeline progress and revenue using tools such as HubSpot, Salesforce, and others.
• Deliver Solutions:
• Present high-impact sales presentations, proposals, and solutions aligned to customer needs and project priorities.
• Market Engagement:
• Attend industry events, trade shows, and client meetings to grow the pipeline and increase brand awareness.
• Stay Informed:
• Maintain a strong understanding of market trends, industry developments, and the competitive landscape.

Key Skills & Qualifications

• 3+ years of B2B enterprise software or technical solution sales, ideally in construction, geospatial, manufacturing, or related fields.
• Proven record of full-cycle sales success—prospecting, negotiation, closing, and exceeding assigned quotas.
• Excellent verbal, written, and presentation skills—able to engage C-suite stakeholders and technical buyers alike.
• Strong proficiency with CRM (HubSpot, Salesforce) and sales engagement tools.
• Drive and self-motivation; able to operate independently in a fast-paced and growth-driven environment.
• Consultative, problem-solving approach and ability to build trust.
• Technical aptitude and willingness to stay current on new products, workflows, and digital solutions.
• Bachelor’s degree preferred.

Join Hexagon Multivista’s innovative sales team and help AECO businesses transform operations with industry-leading capture, analysis, and project management technologies.

USA

We are an equal opportunity employer. We do not discriminate on the basis of age, gender, gender identity or expression, sexual orientation, disability, ethnicity, nationality, religion, marital status, or any other protected characteristic. All qualified applicants are encouraged to apply.

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)

Title: Senior Technical Support Engineer (Care Delivery)

Employment Type: 6-Month Contract-to-Hire

Start Date: ASAP

Work Model: Hybrid – 3 days onsite required

Eligible Locations: Boston, MA | Raleigh, NC | Dallas, TX | Waterloo, Ontario (Canada)

Compensation: 65-68/hr

About the Role

We are hiring a Senior Technical Support Engineer to support a complex production application environment focused on care delivery workflows. This is a hands-on troubleshooting role for someone who enjoys diagnosing real system problems — not a developer stop-gap role.

You will investigate live production issues, analyze application behavior, read backend code, execute SQL queries, and either resolve problems directly or partner with engineering teams to drive fixes.

The ideal candidate is a career technical support professional who takes ownership of issues and thrives in a high-impact operational environment.

What You’ll Do

• Reproduce and diagnose complex production issues
• Read and interpret object-oriented backend code
• Execute advanced SQL queries to validate system behavior
• Identify root cause and resolve issues when possible
• Escalate bugs to engineering with clear technical documentation
• Support ongoing operational stability of the platform
• Work within ticketing systems to manage incidents
• Improve support tooling and workflows
• Collaborate cross-functionally with engineering and operations teams

Required Qualifications

Technical

• Strong object-oriented programming background in Java, Go, or Python (must be strong in at least one)
• Advanced SQL querying skills
• Application-level troubleshooting experience
• Ability to read and debug code (not just run scripts)
• Experience working within ticketing/incident systems

Preferred Qualifications

• Experience as a Senior/Staff/Principal Technical Support Engineer
• Python scripting or automation experience
• Exposure to AI workflow optimization
• Healthcare or life sciences industry experience (nice to have)

Ideal Candidate Profile

• Senior application support engineer (career support track)
• Comfortable reading production code daily
• Strong ownership mindset — drives problems to resolution
• Not a developer seeking a temporary role
• Enjoys deep troubleshooting and operational stability work

Additional Details

• 6-month contract to hire
• Hybrid (3 days onsite required)
• Candidates must reside in Boston, Raleigh, Dallas, or Waterloo
• Immediate start preferred

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.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

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