Overview In this role you will lead end-to-end testing strategies for drug-device combination products, focusing on design verification and related validation activities. You will work with cross-functional teams to align testing with development, manufacturing, regulatory, and quality goals, supporting clinical readiness and market approval. You will influence external partners and internal stakeholders to ensure robust, compliant testing across the product lifecycle. This is an opportunity to shape verification strategies, deepen device and drug development integration, and contribute to successful commercial launches.
Compensation / Benefits- salary range: $142,400.00 - $224,100.00
- annual bonus
- long-term incentive (if applicable)
- comprehensive benefits
- 401(k)
- paid holidays, vacation, compassionate and sick days
Responsibilities- Lead design verification strategies for drug-device programs toward clinical and commercial milestones
- Define design inputs/outputs and develop/execute verification plans, protocols, and reports
- Establish and validate test methodologies and transfer of methods internally or externally
- Oversee aging studies (accelerated/real-time) and bridging studies at device/subassembly/CP levels
- Develop testing readiness and methodologies for stability, filling, final assembly validation, and shipping studies
- Support incoming and release testing at component and CP levels with key functions
- Oversight of external partner verification activities
- Communicate complex technical challenges, timelines, risks, and strategy to stakeholders and partners
- Author/review regulatory submissions related to CP programs (INDs, IMPDs, NDAs, BLAs)
- Lead or support clinical supplies production with respect to device components and CP testing
- Maintain high engagement with cross-functional teams to implement verification strategies
- Stay current with device technologies and global regulations, sharing knowledge across the organization
- Contribute to company reputation through publications, presentations, and professional activities
Key requirements- B.S. in Mechanical Engineering plus 8 years of CP development experience; M.S. plus 5 years; Ph.D. plus 3 years
- Leadership in design verification programs with cross-disciplinary teams
- Comprehensive knowledge of device and drug product development and their interdependencies with design verification
- Strong regulatory knowledge for drug-delivery CPs and related design verification requirements
- Familiarity with ISO 11608, ISO 11040, ISO 80369 and related testing standards and container closure/dose accuracy tests
- Proven ability to apply analytical skills to test method design, development, and validation
- Experience with analytical transfers and QMS/ICH or FDA-standards
- Strong communication, project management, and leadership capabilities
- Willingness to travel
- leadership
- influence without formal authority
- clear communication
- Design Controls
- Design Verification Testing
- DFMEA
