Sr. Manufacturing Engineer (Advanced Manufacturing Engineering)

Description

The Sr. Manufacturing Engineer works independently overseeing the development, implementation, and improvements of the manufacturing process in accordance with product specification and quality standards. In addition, the Sr. Manufacturing Engineer may be expected to mentor others and be a project leader.

Responsibilities

• Recommend and implement improvements to production processes, methods, and

• controls.

• Synchronize manufacturing launch of new or revised products.

• Responsible for tooling design and process development.

• Assure product and process quality by designing test methods, testing finished products and process capabilities.

• Create and approve product drawings, design, and risk 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 production problems.

• Represent manufacturing in cross-functional teams/meeting for new R&D projects.

• Procure and ensure new equipment and tooling meet installation and operational

• qualification requirements.

• Manage manufacturing builds in support of product launch.

• Train employees on current and new manufacturing processes.

• Perform other duties as assigned.

Qualifications

• Bachelor's degree in engineering or related area of study.

• Minimum 10 years' related medical device manufacturing experience.

• Experience working with ISO requirements, FDA regulations, medical device design control, and manufacturing scale-up processes.

• 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.

• Computer skills including Word, Excel and Solidworks.

• Must have 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 $130,000 - $145,000 A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary.

Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.