What You’ll Do:

We are seeking an experienced Senior Scientist, 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 global standards and regulatory expectations.

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

Responsibilities:

• 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

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
• 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

 

Preferred Qualifications:

• 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

Education:

• 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.