Associate Director, Device Quality Engineering (Drug Device Combination Products)

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. 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 RD, 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 Salary Range $155,000 $190,000 USD For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: Kailera Therapeutics, Inc. is an Equal Opportunity Emplo ... (truncated, view full listing at source)