- Report to the Manufacturing Engineering Director and work closely with the Engineering/R&D, Quality, and Manufacturing/Production Teams.
- Sustain current production, while having opportunity to transfer new products from development to commercialization.
- Support supply chain and quality group to resolve part quality issues.
- Determine root cause analysis, corrective actions and create SCARS.
- Recommend and implement vetted solutions.
- Active participant of the Materials Review Board.
- Drive First Article Inspection (FAI) and Cpk processes in qualification of component level parts and sub-assemblies.
- Write and execute protocols and corresponding reports for process validations.
- Create, modify, and release manufacturing process instructions.
- Perform process time studies and determine equipment utilization rates.
- Other sustaining engineering tasks as needed.
REQUIRED SKILLS AND EXPERIENCE:
- Desire 5+ years of experience developing, analyzing and supporting high volume manufacturing processes, tooling, fixtures, and mechanisms.
- Must have medical device experience to include sterile packaging, validations, and verification's.
- Familiar with GMP and ISO 13485.
- Experience in mechanical design, materials, analysis, and manufacturing is required.
- Experience writing IQ/OQ/PQ and process validation documents is required.
- Proven track record optimizing manufacturing processes.
- Ability to write clear, illustrated manufacturing and inspection procedures.
- Machining & use of standard hand and power tools is desired.
- Working well in teams and independently.
- Ability to work and communicate effectively with people from all levels of the organization.
- Must be flexible and willing to perform other tasks as assigned.
Associated topics: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain