4 дня назад
Supplier Engineer - Electronics (Medical Devices)
70 400 - 105 575$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Supplier Engineer - Electronics (Medical Devices): Supporting electronic component suppliers for medical devices through new product introductions, process validations, quality investigations, and continuous improvement with an accent on supplier development, manufacturing processes, and regulated quality systems. Focus on solving supplier issues, executing IQ/OQ/PQ validation activities, analyzing SPC and Gage R&R data, and implementing corrective actions using structured root-cause methods.
Location: Onsite in Acton, Massachusetts, United States; up to 25% travel.
Annual base salary: $70,400–$105,575 USD, with possible incentive compensation.
Company
is a medical device company developing the Omnipod insulin management platform and other wearable drug-delivery solutions.
What you will do
- Act as the day-to-day technical liaison between internal teams and electronic component suppliers.
- Execute defined workstreams across new product introduction, sustaining engineering, continuous improvement, product transfers, and material changes.
- Plan and support engineering qualification and process validation activities, including IQ/OQ/PQ documentation.
- Lead portions of supplier and product investigations, resolve routine to moderately complex issues, and implement corrective actions.
- Analyze process data using tools such as SPC and Gage R&R and support supplier capability assessments.
- Ensure supplier activities comply with medical device standards and internal quality systems.
Requirements
- Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or a related discipline preferred.
- 2–4 years of experience in supplier engineering, manufacturing engineering, quality engineering, or a related field strongly preferred.
- Experience executing engineering or cross-functional projects and working with suppliers or external partners.
- Working knowledge of PCBA and/or battery manufacturing processes and design for manufacturability considerations.
- Experience with process validation, root-cause analysis tools such as 8D, A3, Fishbone, and 5 Whys, and statistical methods including SPC and Gage R&R.
- Familiarity with FDA 21 CFR Part 820, ISO 13485, CAPA, GMP, PFMEA/DFMEA, CTQ concepts, and continuous improvement methodologies.
Nice to have
- Basic exposure to design of experiments and Lean or Six Sigma methodologies.
- Experience supporting NPI projects, product transfers, cost savings, or material changes.
Culture & Benefits
- Full-time onsite work across office, laboratory, and manufacturing environments.
- Medical, dental, and vision insurance.
- 401(k) plan with company match.
- Paid time off and employee wellness programs.
- Collaborative work with cross-functional teams and external suppliers.
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