Senior Manufacturing Engineer, NPI Design Transfer

Responsibilities

• Cook up close with Development and Manufacturing Engineering to lay out and document component manufacturing requirements and processes as devices traverse the development lifecycle.
• Collaborate with cross-functional teams to confirm manufacturing line readiness and make sure proper equipment, space, and personnel are ready.
• Finalize inspection procedures, including determining inspection sample sizes and inspection techniques/gauges for each batch of parts.
• Write work instructions and teach production staff on procedures.
• Draft process risk assessments (PFMEA), process flow charts, and control plans.
• Perform process validation (IQ/OQ/PQ/MVP/TMV) and gauge R&R activities, as needed.
• Solidify tooling documentation for production release using SolidWorks, including tool design updates for manufacturability and tool drawing creation/modification.
• Review process metrics to spot areas for improvement throughout the transfer process.
• Affirm accurate and comprehensive QMS/DMR records through the change order process, including documentation of both finished components and raw materials.
• Monitor transfers post-release for lessons learned or process improvements.
• Provide constructive feedback to the production transfer process and participate in continuous improvement initiatives like creating templates for similar processes.
• Assist in driving manufacturing engineering projects to completion, ensuring the work is done satisfactorily and on time.

Qualifications

• Bachelor's degree in a relevant Engineering discipline.
• 5+ years' experience in a manufacturing environment.
• Familiarity in creating and modifying drawings and models using SolidWorks.
• Strong communication skills, comfortable with providing project status updates at the team level or holding phase gate meetings with functional department managers.
• Demonstrated work ethic and understanding of deadline management.
• Effective interpersonal skills and adeptness in working with a culturally diverse employee population.