Senior Process Engineer (Medtech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Senior Process Engineer (Medtech): Developing and optimizing manufacturing processes for life-saving medical technologies with an accent on NPI, process innovation, and scaling production. Focus on designing automated solutions, executing process validation (IQ/OQ/PQ), and implementing sustainable corrective actions.
Location: Onsite in Danvers, Massachusetts, USA (minimum 5 days a week)
Salary: $101,600 - $152,400
Company
Global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through engineering innovation.
What you will do
- Lead development, optimization, and validation of manufacturing processes for new and existing products.
- Drive process design, equipment selection, and layout to ensure efficient and scalable production.
- Partner with R&D, Quality, Operations, and Supply Chain to support new product introduction (NPI).
- Identify and execute automation opportunities to transition manual processes to automated solutions.
- Implement process controls using statistical methods such as SPC, DOE, and capability analysis.
- Lead process validation activities (IQ/OQ/PQ) ensuring compliance with FDA and ISO regulatory standards.
Requirements
- Bachelor's Degree with at least 4 years of related experience or an Advanced Degree with 2 years of experience.
- Must possess unrestricted U.S. work authorization (sponsorship is only offered for Principal-level roles and above).
- Ability to work onsite in Danvers, MA.
Nice to have
- Experience in medical device or other regulated manufacturing environments.
- Strong background in automation, equipment integration, or advanced manufacturing technologies.
- Experience with plastics processing (injection molding, extrusion) or complex assembly.
- Lean Six Sigma certification or equivalent continuous improvement experience.
- Knowledge of risk management (FMEA) and quality systems.
Culture & Benefits
- Comprehensive health, dental, and vision insurance, including HSA and Flexible Spending Accounts.
- 401(k) plan with employer contribution and match.
- Tuition assistance and reimbursement programs.
- Employee Stock Purchase Plan and Incentive plans.
- Global well-being program (Simple Steps).
- Paid time off and paid holidays.
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