|Reports to: Manufacturing & Engineering Manager
Essential Job Functions:
Creating and revising of Manufacturing and 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.
BSEE or BSIE required, BSME with strong electronic background
Minimum 2 years manufacturing engineering, Medical Device preferred
Line support for new devices and finished goods as well as servicing.
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.
State or Province