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Manager, Process Engineering - NPI (Medical Device Manufacturing)
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Описание вакансии
Текст:
TL;DR
Manager, Process Engineering - NPI (Medical Device Manufacturing): Leading NPI manufacturing engineering teams and developing, validating, and transferring manufacturing processes for orthopedic medical devices with an accent on process capability, design for manufacturability, quality systems, and supplier implementation. Focus on designing tooling and automation, conducting technical reviews, documenting FMEAs and validation protocols, and driving lean and process improvement initiatives.
Location: Austin, Texas, USA. Applicants must already have full-time work authorization in the United States and must not require employment visa sponsorship.
Company
is a medical technology company developing orthopedic products, services, and integrated technologies focused on improving patient outcomes and transforming healthcare workflows.
What you will do
- Lead NPI manufacturing engineers and technicians launching new orthopedic medical devices.
- Act as the primary process and manufacturing expert on cross-functional new product development teams.
- Design, develop, validate, and transfer manufacturing processes, procedures, tooling, and automation within and at suppliers.
- Assess process capabilities, prioritize improvement opportunities, and drive lean and Kaizen initiatives.
- Oversee development builds, technical reviews, manufacturing limits, and design-for-manufacturability input.
- Ensure completion of quality-system deliverables, including BOMs, routers, FMEAs, CAPA activities, validation protocols, and reports.
Requirements
- Bachelor’s degree in science, mechanical engineering, or a related engineering discipline.
- At least 10 years of experience in process or manufacturing engineering.
- At least 3 years of experience managing an engineering team.
- Experience with measurement systems, including CMMs, vision inspection, and profilometers.
- Experience with GD&T and manufacturing process development.
- Full-time U.S. work authorization is required; employment visa sponsorship is not available now or in the future.
Nice to have
- Medical device manufacturing experience.
- Experience with DFM, lean manufacturing, process control, DOE, process validation, FMEA, Six Sigma, or DMAIC.
- Experience with SolidWorks, Mastercam, or Minitab.
- Master’s degree in engineering or experience with metals, plastics machining, or additive manufacturing.
Culture & Benefits
- Collaboration with cross-functional partners, surgeons, and patients.
- Focus on scientific excellence, continuous improvement, and innovation.
- Medical, dental, and vision insurance.
- Spending and savings accounts, 401(k), vacation, sick leave, and holidays.
- Income protection plans, discounted insurance rates, and legal services.
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