Engineering project coordination from prototype to production
Medical device assembly and manufacturing oversight
Iq/oq/pq validation documentation and execution
This role involves taking ownership of end-to-end engineering projects for high-precision medical device components within a regulated environment
Job Summary
This role involves taking ownership of end-to-end engineering projects for high-precision medical device components within a regulated environment.
The successful candidate will lead validation activities including IQ/OQ/PQ while ensuring strict adherence to ISO 13485 and FDA QSR standards.
You will collaborate directly with global healthcare clients to deliver tailored engineering solutions using advanced technologies like Metal Injection Molding and 3D Metal Printing.
Matching Summary
Match Score: 85
This role involves taking ownership of end-to-end engineering projects for high-precision medical device components within a regulated environment.
Skills & Requirements
Must-have
Engineering project coordination from prototype to production
Medical device assembly and manufacturing oversight
IQ/OQ/PQ validation documentation and execution
ISO 13485 and FDA QSR compliance knowledge
Technical documentation and SOP development
Nice-to-have
Experience with MIM, CIM, or 3D metal printing processes
Cleanroom injection molding exposure
Contract manufacturing industry background
Strong stakeholder management and communication skills
Cross-functional team collaboration experience
Key Requirements
Degree or Diploma in Mechanical or Electrical Engineering
Minimum 2 years of experience in project engineering or manufacturing
Familiarity with regulated medical device quality systems