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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 global standards and regulatory expectations.
Job Responsibility:
Lead the design and development of combination products, including autoinjectors, pre-filled syringes, and multidose pens, from concept through commercialization
Develop device and combination product requirements including user and stakeholder needs, 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
Collaborate cross-functionally with clinical, regulatory, commercial, supply chain, and other key functions to ensure integration of 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), test vendors, and consultants to integrate deliverables into the project Design History File
Ensure product development aligns with relevant standards including ISO 11608-1, ISO 11040, ASTM D4169, ISO 14971, and IEC 62366
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
Deep understanding of design controls, 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 with 12+ years of experience. Advanced degree with 10+ years of experience is preferred.
Nice to have:
Experience working in a regulated pharmaceutical or biotech environment
Familiarity with combination product regulations (21 CFR Part 4)
Experience with supplier management and external development and manufacturing partners
PMP certification or formal project management training is a plus