Electrical Engineer/Manufacturing Engineer – Medical Device – San Diego – thriving late stage start up
San Diego, CA | Direct Hire
JOB #: 17052601 - TJ
JOB DESCRIPTION: Are you ready to show your diversity and contribute to a rapidly growing medical device developer/manufacturer? Do you know circuit design inside and out? Have you evaluated Test procedures, assisted production teams with processes and worked with Risk Analysis (14971), FMEA, documentation and validation work? TriStaff is partnering with this thriving Medical Device organization. We are searching for a Manufacturing Engineer who is well dipped in electrical medical devices. The new addition will be elbows deep in circuits, troubleshooting to failure mode, heavy into analysis, while supporting the production team to streamline processes. This is a hands on, pitch in where needed position in an exciting, quick moving environment. Lots of exciting projects on the horizon for 2014, this will be your opportunity to excel at what you do best.
Design and evaluate electrical systems of medical devices used in clinical trials.
Essential Job Functions:
• Create and revise Manufacturing and Electrical Testing Work Instructions including visual aids, Specifications, Inspection and Qualification Documentation.
• Investigate and report field issues, failures and complaints.
• Support Quality System Technical Compliance with participation in Material Review Board, Non-Conforming Material Investigations and Corrective and Preventative Action (CAPA) activities.
• Develop new processes and procedures for new product lines.
• Solve production related problems and document solutions.
• Support manufacturing, process validation, development and product research efforts.
• Participate in design reviews.
• Facility and Equipment Qualification/Validation.
• Verify, validate and document product designs.
• Follow processes and procedures for supporting and developing products.
• Provide Engineering support for other departments as necessary.
• Complete other engineering duties as assigned.
• $ 90,000 to $ 120,000
• Competitive salaries
• Comprehensive medical, dental, and vision plans
• Group life and disability coverage
• Paid time off
• Paid holidays
• 401(k) Savings Plan
• Employee Stock Purchase Plan (ESPP)
• Flexible Spending Accounts (FSA)
• Business travel accident coverage
• Educational reimbursement
• Employee Assistance Programs
• 5-10 years' experience in manufacturing engineering, Medical Device experience required.
• Electrical Engineering Experience in a manufacturing environment – ability to determine electrical test processes to characterize devices.
• Be able to read and understand both electrical and mechanical drawings.
• Experience with product development transfer from concept to production.
• Experience with product and process validation.
• Experience generating product development documentation (plans, schedules) preferred.
• Experience with FDA GMP Part 820, CE, UL and ISO 13485 preferred.
• Excellent teamwork skills required.
• Excellent written and verbal communication skills required.
• Proficient with standard Microsoft Office tools, Statistical Software, CAD.
• BSEE or BSME with strong electronic background.
FOR OTHER OPPORTUNITIES AND TO REGISTER WITH TRISTAFF, PLEASE VISIT OUR WEBSITE AT www.tristaff.com
KEY WORDS: Electrical Engineering - Risk Analysis 14971, FMEA, Validation, Six Sigma/Lean Mfg, documentation, Manufacturing Transfer