Senior Manufacturing Engineer
Posted on: January 18, 2023
Senior Manufacturing Engineer / FDA Breakthrough Medical Device
/ CAD / NPI
Title: Senior Manufacturing EngineerLocation: Sunnyvale, CA
Company:They are a medical device company focused on addressing the
already well-recognized shortcomings in treating cardiac rhythm
disease through Cardiac Resynchronization Therapy (CRT).
Job Description:This Senior Manufacturing Engineer will make a
direct impact in successfully manufacturing highly complex novel
Class II & III electromechanical medical devices. You will design,
procure, and qualify critical tooling, fixtures, equipment, and
documentation to achieve high manufacturing quality and
- Design, develop, and implement fixtures and tooling to increase
quality, capacity, reliability, and yields.
- Responsible for the installation of new equipment, and setting
up proper preventive maintenance and calibration plans.
- Develop protocols and coordinate validation of equipment and
- Lead the design and development efforts for significant product
and/or process changes.
- Lead and conduct experiments utilizing DOE methodology and
other design tools.
- Work with Quality Engineers to investigate product/process
failures and collaborate on developing immediate and preventive
- Bachelor's Degree in Mechanical Engineering or related
- 4+ years in a medical device manufacturing environment.
- Working knowledge of cGMP requirements for medical device
manufacturing per FDA QSR and ISO13485.
- Demonstrates proficiency in coordinating the design and
development of equipment and fixtures.
- Solid modeling/CAD/CAM experience is a plus (SolidWorks).
- SPC (Statistical Process Control) knowledge.
- Catheter, Active Implantable, and/or Class III Medical Device
- New Product Introduction (NPI) experience
Senior Manufacturing Engineer / FDA Breakthrough Medical Device /
CAD / NPI
Keywords: Lumicity, Sunnyvale , Senior Manufacturing Engineer, Engineering , Sunnyvale, California
Didn't find what you're looking for? Search again!