Manufacturing Engineer II (AME)

The Manufacturing Engineer II (AME) develops, implements, and improves manufacturing processes in accordance with product specifications and quality standards. Works closely with the R&D and the Manufacturing teams to transfer new products into manufacturing. Coordinates and manages the manufacturing launch of new or revised products. Responsibilities

• Perform tooling design and process development.
• Assure product and process quality by designing test methods, testing finished products and process capabilities.
• Create and approve test protocols and reports, validation master plans, FMEAs, product drawings and additional documents.
• Establish and perform verification and validation activities including design verification testing, process and packaging validation and shelf-life studies.
• Prepare product and process reports by collecting, analyzing, and summarizing.
• Evaluate and solve complex and/or new manufacturing processes required from new product implementation.
• Assist in the successful transfer of products from R&D into manufacturing to meet company goals for timelines and yields.
• Represent manufacturing in cross-functional teams/meeting.
• Ensure new equipment and tooling meets installation and operational qualification requirements.
• Able to work independently and as a part of a cross-functional team.
• Train employees on current and new manufacturing processes.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in Engineering or related equivalent experience.
• Minimum 4 years’ related medical device experience.
• Experience reading and preparing technical documentation.
• Working knowledge of standard machine shop equipment and processes.
• Expertise with medical device manufacturing equipment and processes.
• Understanding of medical and technical development.
• Experience working with ISO requirements, FDA regulations, medical device design control, and manufacturing scale-up processes.
• Demonstrated computer skills including Word, Excel and Solidworks.
• Demonstrated ability to communicate concepts, ideas, and knowledge effectively and clearly to other individuals and teams both verbally and in writing. 

Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $110,000 - $115,000. A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary.