Principal Engineer job in Cambridge, USA

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Job type: Permanent

Discipline: Manufacturing, Design

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Principal Engineer - Medical Device with a biotechnology company located in Cambridge, MA.

Job Responsibilities:

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.

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