What You’ll Do:

We are seeking a highly skilled and experienced Device Quality Engineer to support the development, validation, and launch of pre-filled syringe and autoinjector-based drug-device combination products. This role is critical in ensuring that combination products meet regulatory, quality, and performance standards throughout the product lifecycle.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Lead quality engineering activities for combination product development, including design controls per 21 CFR 820 and ISO 13485
• Ensure appropriate quality oversight at vendors and approve Vendor GMP documentation
• Drive risk management processes in accordance with ISO 14971, including hazard analysis, FMEA, and risk-benefit assessments
• Apply statistical techniques to analyze design verification, validation, and manufacturing data (e.g., DOE, regression analysis, capability studies)
• Collaborate cross-functionally with R&D, Regulatory Affairs, and Operations to ensure robust design and manufacturing processes
• Manage quality oversight of Contract Manufacturing Organizations (CMOs) and Contract Test Labs (CTLs), including audits, investigations, and quality agreements
• Support design transfer activities and ensure compliance with combination product regulations (21 CFR Part 4)
• Author/review quality documentation including protocols, reports, specifications, and risk files
• Participate in root cause analysis and CAPA investigations related to device performance and reliability
• Implementation and management of Device Quality System Procedures
• Managing/resolving device related product complaints
• Support regulatory submissions by providing quality and risk documentation

Required Qualifications:

• 10+ years of experience in medical device or combination product quality engineering
• Proven experience with pre-filled syringes and autoinjectors in a regulated environment
• Deep understanding of design controls, ISO 14971, and statistical analysis tools (e.g., Minitab, JMP)
• Experience working with CMOs and CTLs, including quality oversight and technical collaboration
• Strong knowledge of applicable regulations and standards (21 CFR 820, ISO 13485, ISO 14971, EU MDR)
• Proficient in Veeva QualityDocs and Veeva QMS
• Proficient in Word, Excel, PowerPoint, and SharePoint
• Excellent communication, problem-solving, and project management skills

Preferred Qualifications:

• Experience with combination product submissions (IND, NDA, BLA)
• Six Sigma or ASQ certification
• Familiarity with Human Factors Engineering and usability testing

Education:

• Bachelor’s or Master’s degree in Engineering, Biomedical Engineering, or related field