Lead Medical Device Process Development Engineer

Katalyst CRO

Harrisburg (Dauphin County)

On-site

USD 120,000 - 180,000

Full time

2 days ago

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Job summary

Katalyst CRO is seeking an experienced Staff Process Development Engineer to lead manufacturing process development for NPD, design changes, and technology transfer in a regulated medical device setting.

The role requires collaborating with R&D, Product Development, Manufacturing Engineering, Quality, and Operations to ensure manufacturability, scalability, and operational excellence. Strong DFMA, ATR, and DFSS experience is essential.

Qualifications

Bachelor's or Master's degree with extensive experience in process development/manufacturing within regulated industries.
Proven track record supporting NPD and product commercialization.
Strong DFMA expertise and experience with ATR analysis.
Advanced CAD skills (SolidWorks) for product/assembly development.
Experience with DFSS, DOE, SPC, process validation, and pFMEA.

Responsibilities

Lead process development and industrialization for new product introductions and transfers.
Collaborate with R&D and Product Development during concept, feasibility, and design transfer phases.
Perform DFMA assessments to optimize architecture, cost, quality and throughput.
Conduct ATR analyses and tolerance stack-up evaluations for robustness.
Develop manufacturing strategies, tooling, fixtures, and automation solutions.
Define KPIVs/KPOVs to ensure process capability and product quality.
Design, execute, and analyze DOE and process characterization studies.
Lead pFMEA activities and implement risk mitigation plans.