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Manufacturing Process Engineer

Summary:

Provide engineering leadership and support in a rapidly growing catheter production environment. Drive continuous improvements and optimization of manufacturing processes, equipment and materials to ensure high quality products, improve productivity and reduce costs.  Support the successful transfer from development to full scale production of class II and III medical devices.

Responsibilities:

• Assess process capabilities, prioritizes process improvement opportunities, and innovate and implement process improvements on platform or derivative projects.
• Apply technical knowledge to innovate, design, and develop semi-automated / automated manufacturing processes.
• Provide requirements input to catheter engineering as required to insure that necessary equipment and fixtures are developed to meet quality, ergonomic, safety, and cost/thruput considerations.
• Drive improvements to process validation through application of risk analysis (FMEA), DOE, verification and validation, gage R&R, capability studies and other statistically meaningful techniques.
• Implement improved process monitoring and control through the use of SPC and automated data collection.
• Investigate quality issues for root cause and recommend/implement/document corrective actions. 
• Work closely with materials management, quality, and vendors to assure that purchased material meets objectives.
• Lead strategic outsourcing / insourcing projects.
• Lead cross functional project teams as required to drive process optimization.
• Apply Lean Manufacturing principles in support of continuous improvement in the production lines.
• Other duties as assigned.

Qualifications:

• Bachelors degree in Engineering is required.  A degree in Mechanical, Materials, or Chemical Engineering preferred.
• 3+ years of experience in a manufacturing, process-oriented environment in a regulated industry
• Strong project management experience/skills
• Proven knowledge of SPC, DOE, statistical techniques (Six Sigma experience preferred)
• Lean Manufacturing experience
• Creative problem solver
• Must be a self-starter
• Working knowledge of FDA QSR / ISO 9000 regulatory requirements
• Must be challenged by a team-based environment which places high degree of emphasis on accountability for yield improvement, cost reduction and quality/GMP compliance

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