Medical Device - Manager/Director Manufacturing Engineering; Sr. Qualilty Eng.; Sr. Mfg. Eng.

I'm a medical device recruiter specializing in the placement of R&D, Quality, and Manufacturing engineers and managers. My clients vary in size from development-stage, to very large, minimally invasive cardio/peripheral vascular medical device companies. My clients are located primarily in So Cal, and the Bay Area. 


My website:  www.cambridgerecruiters.com (client list & placement history)




Manager/Director Manufacturing Engineering - Salary: 110-120K for Mgr, 130-150K for Director

Development-stage medical device company is looking for hands-on leader to manage team of Manufacturing Engineering professionals (4 eng's, 2 tech's) for catheter-based implantable medical devices.  The company is privately-held, pre-IPO, venture-funded and is currently involved in US and OUS clinical trials. 


Requirements:  Hands-on Mechanical/Manufacturing Engineering background with catheter-based devices.  Degreed Engineer with at least 7-10 yrs experience, with 2+ yrs people/project management experience.The WRONG person for this position:  Pure Managers - hands-off managers who are or who have been removed from the day-to-day activities of engineering.

The RIGHT person for this position:  Someone who is an engineer first, and who has both the technical as well as the leadership skills to lead the team.  The person they hire will feel comfortable being a hands-on contributor (writing reports, creating drawings) as well as coordinating/priortizing tasks for the group, and who can technically mentor the younger engineers.

The position will report to a VP, so they'll consider making the title either Manager or Director (depending on the candidate) and will adjust the salary accordingly.  Equity position.




Quality Engineer/Senior Quality Engineer (Irvine Area) up to $95,000 base salary plus bonus


Start-up implantable device company, venture-funded, pre-IPO.  Multiple device company, one of which has licensing agreement and this position will partially be responsible for transferring the device to the other company.  Second-generation minimally-invasive implantable devce also in early development.  Strong engineering accumen needed, hands-on quality/process engineering background a must. 





Responsibilities include performing process validations, data analysis, and verification of test results to draw statistical conclusions from the validation study, developing quality assurance specifications, test methods, sampling plans and related written procedures.

-BS Degree, MS preferred (Engineering- BSME, Materials Science, Biomedical).

-5+ years Quality Engineering experience with a MEDICAL DEVICE COMPANY.

- Must Have experience with Nitinol devices & implantables

- Must have experience with Fatigue, Corrosion, Metal Forming


-Must have experience with DOE's, Statistical Process Control.

-Experience with equipment validations preferred.

-ASQ Certified Quality Engineer a plus.





Manufacturing Engineer/Senior Manufacturing Engineer (Irvine Area) Up to $100k base

-BS Degree, MS Preferred (Engineering - BSME, Industrial, EE, or Manufacturing Technology).

-5+ yrs experience supporting medical device production including tooling, line management etc. (Catheters/Stents preferred).

-Must have experience with a MEDICAL DEVICE COMPANY.

-Process/equipment validations experience preferred.

-Requires experience with IQ/OQ/PQ's & DOE's.

-Tooling & fixture design experience a plus.

-Machine shop experience a plus.

-AutoCad and/or SolidWorks experience a must!