Proclinical is currently recruiting for a Principal Engineer - Medical Device with a biotechnology company located in Cambridge, MA.
- Ambitious and high performing with exceptional interpersonal and communication skills
- With the ability to influence behaviors, manage stakeholders, negotiate and resolve challenges with tact and diplomacy
- Experience in combination product (such as autoinjector, pre-filled syringe, wearable injector, pen injector, reconstitution device etc.), implants, ophthalmology and digital health is preferred
- Proven experience in launching of combination product through the entire development cycle in a CMC environment is highly desired
- Deep device design and development knowledge of first principles analysis, tolerance analysis, FEA, DOE, Design for Six Sigma (DFSS) and Design for Manufacturing (DFM) etc.
Skills and Requirements:
- Bachelor's Degree in Engineering required, Master's Degree preferred- plus 14+ years' experience in medical device design and process development or related area.
- Deep knowledge of the regulatory and compliance requirements of device/combination products design controls and manufacturing in US/EU/ROW. Experience with 510k, PMA, HDE, NDA, BLA, MDD, MDR is preferred
If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 267-297-3257.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.