Sr NPI and Validation Engineer (Onsite - Acton, MA)

This role combines leadership in software validation quality engineering with responsibilities in new product introduction (NPI) and process validation. The Senior Software Validation Quality Engineer / Senior NPI and Validation Engineer ensures compliance of IT systems and automated data processing tools while driving the successful transition of new products into manufacturing.

Responsibilities

• Lead Design Assurance and Quality activities throughout IT Systems lifecycles for GxP and non-GxP systems, ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and General Principles of Software Validation.
• Review system requirements, specifications, design documents, validation plans/reports, test protocols/reports, traceability matrices, and process validations; provide timely feedback.
• Provide expertise in software requirements, specifications, verification/validation protocols, and planning documentation.
• Support cybersecurity risk management for US and international requirements.
• Validate software tools and apply knowledge of IT Systems Lifecycles, including Risk Management and Change Control.
• Ensure timely and effective launch of new products into manufacturing through collaboration with R&D and systems teams.
• Provide validation expertise to manufacturing engineers, driving process improvements for quality, service, and cost objectives.
• Support global manufacturing engineering in equipment and process validation activities (FAT, SAT, IQ, TMV, PQ).
• Develop and standardize global processes for design transfer and manufacturing.
• Work with supply chain to align manufacturing capacity with volume and forecast requirements.
• Drive cost savings projects through data analysis and interpretation.
• Develop and deliver training to build global engineering team capabilities.
• Ensure compliance with safety rules, quality policies, cGMP, FDA 21 CFR Part 820, and ISO 13485.
• Interface with cross-functional teams (IT, Manufacturing, Operations, R&D, Regulatory Affairs) and external vendors.

Requirements

• BS degree in engineering, scientific, computer systems, or quality management curriculum (Master’s preferred).
• Minimum 5 years of experience in Software Quality Engineering within FDA, ISO, or other regulated environments.
• Experience with Quality/Design Assurance, Design Control, and Software Development for FDA Class II/III medical devices, mobile apps, cloud-based systems, and cybersecurity.
• Familiarity with GAMP 5 guidance and risk-based validation of computerized systems, COTS software, and SW tools.
• Working knowledge of FDA 21 CFR Part 820 and ISO 13485 quality system standards.
• Experience with medical device manufacturing process validation and equipment validation (FAT, SAT, IQ, TMV, PQ).
• Expertise in data analysis tools (DOE, process development) and structured problem-solving (DMAIC, Six Sigma).
• ASQ, CSQE, or other software quality certificates are beneficial.

Skills

• Strong verbal and written communication; ability to collaborate across organizational levels.
• Ability to prioritize and manage multiple critical project timelines in a fast-paced environment.
• Analytical and problem-solving skills with a systematic, methodical approach to decision-making.
• Technical aptitude with hands-on experience in assembly methodologies, automation, robotics, sensors, and HMIs/GUIs.
• Ability to read and interpret technical drawings/manuals; mechanical aptitude for cam-driven linkages and discrete component assembly.
• Excellent attention to detail, organizational skills, and process discipline.
• Thirst for knowledge, curiosity, and resilience in high-stress environments.

Benefits

• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off (PTO).
• Additional employee wellness programs.

Pay

Annual base salary range: $94,600 – $141,850 (U.S.-based positions only). Eligible for incentive compensation.

Schedule

This position requires on-site work (office/plant/lab).