Process Engineer II, Advanced Manufacturing Team
$84,000–$126,000 year
On-site · Danvers, Massachusetts, United States
Job Summary
Lead manufacturing process development and optimization for medical technologies within the Advanced Manufacturing Engineering (AME) team. Collaborate with Product Development, Quality, Manufacturing, and Operations to design and implement robust manufacturing processes that meet performance, quality, and regulatory requirements. Contribute to new product development initiatives and continuous improvement efforts; support feasibility studies, technology scouting, and concept development; apply statistical analysis and data-driven methods to evaluate process performance and support decisions. Design and transfer processes into manufacturing with scalable production readiness; ensure processes are compatible with SPC and measurement systems. Maintain thorough documentation (process development reports, validation documents, standard work). On-site five days per week as part of a cross-functional team delivering the extraordinary in patient care.
Required Qualifications
- Bachelor's degree in a relevant engineering field or equivalent
- minimum 2 years of relevant experience or Master's with 0 years
- Experience with manufacturing process development or process engineering
- Familiarity with SPC, process capability analysis, data-driven problem solving
- Knowledge of medical device manufacturing or regulated environments (FDA/ISO) preferred
- Experience collaborating with R&D, Quality, and Operations
- Lean or continuous improvement familiarity
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