Description

Description

Works independently overseeing the development, implementation, transfer 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. Apply structural thinking to solve issues (DMAIC/PDCA/Lean Six Sigma
• Provide robust process analysis based on statistical data
• 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

• Reading and preparing technical documentation.
• Documentation and communication skills
• Working knowledge of standard machine shop equipment and processes.
• Expertise with medical device manufacturing equipment and processes.
• Expertise on medical process transfers
• Understanding of medical and technical development.
• Computer skills including Word, Excel and Solidworks minitab
• Must have demonstrated ability to communicate concepts, ideas, and knowledge effectively and clearly to other individuals and teams both verbally and in writing.
• Bachelor’s degree in engineering or related area of study.
• Experience working on medical process transfer
• Minimum 7 years’ related medical device manufacturing experience.

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