Staff Supplier Industrialization Engineer (Medtech)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Staff Supplier Industrialization Engineer (Medtech): Serving as the critical technical bridge between US-based R&D and global contract manufacturing networks to ensure scalable, high-quality production of medical EEG platforms. Focus on leading NPI industrialization, managing international vendor relationships, and optimizing manufacturing processes for complex electromechanical systems.
Location: Must be based in or able to work from Sunnyvale, CA (with up to 30% international travel).
Salary: $142,000 - $169,000 USD
Company
is a medical technology company transforming the diagnosis and management of patients with serious neurological conditions through its novel, point-of-care EEG platform.
What you will do
- Act as the primary technical authority for international contract manufacturing and component vendor networks.
- Drive the transition of precision medical devices from domestic design centers to global production lines.
- Lead technical RFP evaluations, vendor qualifications, and on-site technical audits.
- Develop and maintain capacity models, should-cost analyses, and continuous yield improvement programs.
- Manage the validation lifecycle, including IQ/OQ/PQ protocols and Supplier PPAP frameworks.
- Collaborate with R&D to provide DFM/DFA feedback and ensure high-quality electronics manufacturing standards.
Requirements
- B.S. in Mechanical, Electrical, Manufacturing, Mechatronics, or Biomedical Engineering (M.S. preferred).
- Over 7 years of engineering experience in supplier, manufacturing, or industrialization roles.
- At least 3 years of direct oversight managing international contract manufacturers and component vendors.
- Proven experience navigating electromechanical products through the full NPI lifecycle into high-volume production.
- Deep knowledge of FDA 21 CFR 820, ISO 13485, and manufacturing frameworks like PPAP and PFMEA.
- Willingness to travel up to 30% to international and domestic manufacturing sites.
- Advanced proficiency in Mandarin is highly advantageous.
Culture & Benefits
- 100% Employer-paid health benefits for employees.
- 401(k) with generous company match.
- Equity opportunities and Employee Stock Purchase Plan (ESPP).
- Flexible paid time off and 13 paid holidays.
- Monthly cell phone stipend and excellent parental leave policy.
- Mission-driven culture focused on transforming critical care.
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