Associate Director, Device Engineering

Kailera Therapeutics•Waltham, MA

7d•Hybrid

About The Position

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. 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)

Requirements

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
Bachelor’s degree in mechanical engineering, Biomedical Engineering, or related field.

Nice To Haves

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
Advanced degree preferred.

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