Principal Engineer Job

PRINCIPAL ENGINEER needed for a CONTRACT opportunity with Yoh's client located in THOUSAND OAKS, CA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- B.S.M.E. degree.
- Medical Device industry experience.
- Ten (10) years relevant experience.

WHAT YOU'LL BE DOING:

- Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices.
- The Principle Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices.
- The role of the Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

WHAT YOU NEED TO BRING TO THE TABLE:

- BS. in Mechanical Engineering and previous experience in a medical device industry.
- Ten (10) years current experience with engineering processes and procedures. Led projects from development through the 510k and PMA approval process.
- Strong background in engineering and commercialization of electro-mechanical medical devices.
- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
- Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
- Experience in drug/device combination product design and development.
- Qualified candidates with either a strong Mechanical Engineering, OR Systems Engineering background need apply and will be considered

IF THIS SOUNDS LIKE YOU, APPLY NOW!

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Contact us if you are an individual with a disability and require accommodation in the application process.

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