Associate Director, Device Engineering

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 an experienced Associate Director, Device Engineering, to lead the development and launch of drug-device combination products, with a strong emphasis on autoinjectors, pre-filled syringes, and multidose pens. This role will drive cross-functional collaboration across CMC, quality, regulatory, manufacturing, clinical, and commercial teams to ensure robust product development aligned with meeting patient needs, global standards, and regulatory expectations. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month). Responsibilities: Lead combination product development projects (prefilled syringes, autoinjectors, and/or multidose pens) from concept through commercialization Build and execute project plans with clearly defined risks and milestones Develop device and combination product requirements, including user and stakeholder needs and technical requirements, and ensure appropriate engineering translation and subsequent verification and validation of requirements Oversee and ensure compliance with design controls per FDA and ISO 13485 requirements Manage risk management activities in accordance with ISO 14971, including hazard analysis, FMEA, and risk mitigation strategies Drive design verification and validation activities, including test method development, protocol execution, and documentation Oversee human factors and usability engineering efforts, ensuring compliance with FDA guidance and IEC 62366 Facilitate design transfer to manufacturing, ensuring smooth transition and scalability Partner cross-functionally with CMC, quality, regulatory, clinical development, commercial/marketing, supply chain, and other key functions to ensure critical inputs are integrated into device development activities Author relevant portions of regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for devices and combination product programs Manage and collaborate with vendors, including Contract Design and Manufacturing Organizations (CDMOs) and suppliers, to ensure components and products meet quality and technical requirements and to integrate deliverables into the project Design History File at various stages of development and manufacturing Manage and collaborate with contract test labs to ensure testing strategy, method validation, and test execution are aligned with relevant standards and quality and technical requirements and integrate testing results into the Design History File Ensure product development aligns with relevant standards including ISO 11608-1, ISO 11040, ASTM D4169, ISO 14971, IEC 62366 Required Qualifications: Minimum of 10+ years of experience in medical device or combination product development, with at least 3 years in a team leadership role Proven experience with autoinjector, pre-filled syringe, or multidose pen development and launch, including authoring clinical and commercial regulatory submissions Deep understanding of design controls, design verification, test method development and validation, risk management, human factors, and design transfer Strong knowledge of applicable regulatory standards and guidance documents Excellent communication, leadership, and cross-functional collaboration skills Preferred Qualifications: Experience working in a regulated pharmaceutical or biotech environment Familiarity with combination product regulations (21 CFR Part 4) Experience with supplier management of external development, testing, and manufacturing partners PMP certification or formal project management training is a plus Education: Bachelor’s degree in mechanical engineering, Biomedical Engineering, or related field. Advanced degree preferred. Salary Range $159,000 — $195,000 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 Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances. E-Verify: Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires. #LI-Hybrid