Manufacturing Engineer II

About the role

The Manufacturing Engineer II will lead process development, new product launches, and continuous improvements in a medical device and data center industry contract manufacturing environment. Responsibilities include creating and implementing lean processes, leading process improvement projects, developing manufacturing documents, and communicating with customers and internal stakeholders.

Responsibilities

• Create and implement lean processes in a cellular environment that incorporate machining, sheet metal fabrication, and electro-mechanical assembly with associated sub- and outside-processing (e.g., powder coat, metal finishing, welding, laser cutting, and electrical harness assembly).
• Complete launch readiness NPI deliverables associated within a manufacturing environment (i.e., design transfer).
• Lead process improvement projects at the technical level including analyzing the data, creation of the problem statement, execution of methodology, and outlining the benefits.
• Execute technical manufacturing activities including but not limited to MRB, CAPA, ECO approval & implementation, root cause analysis and effective corrective action countermeasure, deviation authorization, training, etc.
• Define, produce and implement manufacturing documents including routings, standard work, method sheets, and process work instructions.
• Create and execute validation protocols, processes and material evaluations.
• Communicate and provide influence over complex issues with customers and internal stakeholders both face-to-face on site and remotely (e.g., TEAMS).
• Investigate, develop, justify and implement new process technologies to reduce costs.
• Collaborate with development, programmers, machinists and suppliers to evaluate designs for manufacturability and cost reduction.
• Adhere to all safety and quality requirements including but not limited to: Quality Systems, U.S. Food and Drug Administration (FDA) regulations, ISO, company policies and operating procedures, and other regulatory requirements.

Requirements

• Bachelor’s Degree in an engineering or equivalent technical field.
• 5+ years of work experience in a similar technical role(s).
• Demonstrated strong problem-solving skills and a go-to toolbox of techniques.
• Ability to provide solid rationale and justification for process improvement changes.
• New Product Introduction experience.
• Understanding of metals fabrication, preferably sheet metal fabrication, processing (weld and finishing), and inspection.
• Ability to work and collaborate in a team environment.
• Strong written, presentation, and oral communication skills.
• Experience in medical device manufacturing as a Contract Manufacturer.
• Proficiency in Microsoft Office Suite.
• Working knowledge of ISO and FDA regulations.