Description
Duties and Responsibilities:- Plan, design, develop and execute production improvement projects including all necessary documentation.
- Designs and implements processes, mechanical tests, and fixtures/jigs for assembly, inspection and test to improve product quality and increase productivity or reduce costs.
- Plan, write, perform, and review validation IQ/OQ/PQ protocols and reports for all new or modified production equipment.
- Develop test plans, protocols, and reports to ensure designs meet product and part specifications, regulatory requirements, and applicable standards for new equipment and processes.
- Collaborate with contract manufacturers and suppliers to transition and qualify new products.
- Provide technical guidance, as needed, to suppliers to ensure sound engineering or operations practices.
- Hands on investigation and testing of current and new product / process issues.
- Collaborates and communicates with company management, operations, marketing, supply chain, quality assurance, suppliers, and other departments.
- Provides manufacturing engineering feedback on new products and processes.
- Develops and maintains project timelines and provides updates and feedback to project leadership.
- Accomplishes tasks while conforming to the company quality system procedures.
Education/ Experience:
- Bachelor's degree (B. S.) in Mechanical Engineering, Bioengineering, or related field from four-year college or university with 3+ years of relevant industry experience and/or training.