Product Support Engineer Mechanical/Electrical
Orange County Metro Area, CA
Lake Forest, CA
This position will provide needed technical support to Manufacturing project requests (cost improvements, obsolescence, corrective actions) for electromechanical/mechanical post market products: Analyze and trouble shoot design and process changes, document impact on product design to support electrical/electromechanical design and process changes, complaint and risk analysis (in compliance to EN ISO 14971), technical file and product compliance documentation for ophthalmic Surgical Instrumentation products.
This position will also support R&D project activities required for compliance to new European Medical Device Regulation (MDR), including managing and reporting technical product data, materials remediation (for RoHS, REACH,SVHC compliance) labeling updates and technical file updates (required to maintain European registration (CE mark) and will work to assess and maintain product compliance to existing and future regulations and product performance and safety standards and reporting (IEC, EN, ISO, etc.)
The successful candidate will be responsible for completing work requests as assigned by engineering teams and management.
- 5+years of experience ideally in the medical device industry
- Experience with product Verification & Validation
- Medical Device Design Control including risk assessment, management and reporting
- Experience with Corrective and Preventative Action (CAPA) including root cause analysis, problem solving and redesign of devices to meet requirement
- Familiar with PRO-E and other Windchill product data management applications is preferred
- Excellent written and spoken communication skills
- Proficient in MS Office applications
- Bachelors in Mechanical or Electrical Engineering