Senior/Principal Engineer or Scientist, Combination Products
Hybrid · Munich, Bavaria, Germany or Bern, Bern, Switzerland
Job Summary
Senior/Principal Engineer or Scientist in combination products delivering technical leadership across design controls, CMC, QA, and regulatory activities for pharma/biotech/medical device programs. Directs development strategy and execution, develops and reviews complex technical documentation, oversees risk management and verification/validation activities, and provides regulatory submission support. Leads multi-year development programs, mentors junior resources, and ensures compliance with Kymanox and external standards. Travel up to 10%. Hybrid work model with offices in Munich (Germany) and Bern (Switzerland).
Required Qualifications
- Bachelor’s degree in engineering (e.g., Biomedical, Mechanical, Chemical) or a related science field
- 8+ years of experience in medical device, pharmaceutical, or combination products industries
- Direct experience with pre-filled syringes, autoinjectors, co-packaged kits, inhalers, and/or other combination product platforms
- Strong leadership and mentorship capabilities with ability to lead and mentor junior staff
- Experience providing senior technical leadership across product development activities (design controls, risk management, QMS/quality system requirements)
- Experience coordinating regulatory submissions and regulatory affairs support for clinical/commercial programs
- Ability to operate across multiple client quality systems and development frameworks
- Strong written and verbal communication skills in English (additional languages a plus)
- Willingness to travel up to 10%
- Experience in a startup or professional services environment is favorable
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.