обновлено 4 часа назад
Senior Process Engineer (MedTech)
103 200 - 154 800$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Process Engineer (Advanced Manufacturing): Developing and optimizing manufacturing processes for medical technologies with an accent on NPI, process innovation, and scalability. Focus on implementing automation solutions, performing process validation (IQ/OQ/PQ), and ensuring regulatory compliance with FDA and ISO standards.
Location: Onsite 5 days a week in Danvers, Massachusetts, USA. Must have unrestricted U.S. work authorization.
Salary: $103,200 - $154,800
Company
is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life.
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, 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.
- Develop and implement process controls using statistical methods (SPC, DOE, capability analysis).
- Lead process validation activities (IQ/OQ/PQ) and ensure compliance with FDA and ISO standards.
Requirements
- Bachelor's Degree with 4+ years of related experience or an Advanced Degree with 2+ years of experience.
- Unrestricted U.S. work authorization is required at the time of hire.
- Ability to work onsite 5 days a week in a manufacturing environment.
Nice to have
- Experience in medical device or other regulated manufacturing environments.
- 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 process validation, risk management (FMEA), and quality systems.
Culture & Benefits
- Comprehensive health, dental, and vision insurance.
- 401(k) plan with employer contribution and match.
- Paid time off and holidays.
- Employee Stock Purchase Plan.
- Tuition assistance and reimbursement.
- Global well-being program (Simple Steps).
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