Electronics Manufacturing EngineerApply Now
- Ontario, CA
NPI/ Design Transfer:
- Create and/or maintain product documentation for investigations, test protocols and reports, design drawings modifications as per quality and regulatory guidelines, (DHF & DMR).
- Establish engineering test plans/procedures against designs, and performs functional verification and reporting.
- Act as liaison for R&D team for activities involving cross functional teams including QA, OPS, and Supply Chain.
- Works in conjunction with scientists and other engineers in architecture definition, technical reviews and requirements decomposition to develop sub-system level requirements and IVD design documentation for product commercialization.
- Design Review
- Confer with product development team to ensure manufacturability of new products introduced to manufacturing.
- Collaborate with product development team to design tooling and fixtures to support new products.
- Help to investigate various types of new jigs, fixtures, machinery and equipment for production.
Medical Device Manufacturing Experience
- Will help to ensure engineering data and assembly procedures are complete and accurate to ensure conformance to the following standards:
- ISO 13485
- FDA CFR 821 (Medical Device Tracking)
- CE-IVD (Europe)
- Manufacturing Validation (IQ/ OQ/ PQ)
- Work with multiple technical disciplines including QA to bring most effective solutions to resolve CAPA’s in a timely manner.
- Understand all processes in manufacturing (electronics, mechanical) and maximize efficiencies, quality and safety of operations.
- Identify quality and process enhancements for the manufacture of instruments.
- Work closely with production personnel to ensure consistent product flow.
- Work closely with multi-functional teams including product development and QA, to address on-going manufacturing issues, supplier quality, and field problems.
- Perform time studies and load standard rates into ERP system.
- Help to generate ECOs for revision control of product specific documents.
- Help to facilitate the design transfer of subassembly manufacturing and integration knowledge to our supporting sites.
- Help to conduct manufacturing process FMEAs.
- Review and correction of Documentation (Procedures, Work Instructions, Forms).
- Participate in sub-system design and integration activities, monitor against performance, cost, schedule and quality/reliability objectives.
- Uses technical knowledge and significant problem-solving ability to conduct investigations of failures/complaints, and ongoing production issues, to determine and identify root cause.
- Provide technical support for released product lines, Manufacturing and Customer Service as required.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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