Manufacturing Engineer (Medical Devices)

Internal Title: Product Engineer 2

Responsible for supporting product lifecycle activities, including new product introduction, product transfer, and ongoing manufacturing operations. This role ensures product quality, yield, and compliance through engineering evaluation, troubleshooting, and continuous improvement initiatives. Collaborates cross-functionally to drive process enhancements, cost optimization, and operational excellence, enabling smooth transition from design to production and sustaining high-performance standards throughout the product lifecycle.

Position Responsibilities:

Common Responsibilities:

• Support and drive product transfer into manufacturing.
• Perform data trending and analysis.
• Apply FMEA, DOE, and statistical analysis to optimize product quality and reduce costs.
• Drive process improvements, cost reduction, and product sustaining activities.
• Manage Engineering Change Request and Notifications (CRs and CNs), including updates to work instructions and test requirements.
• Support documentation: engineering drawings, BOMs, test reports, assembly procedures, and validation plans.
• Participate in continuous improvement initiatives and operational excellence programs.
• Frequent cross-functional collaboration and occasional travel to other sites.

Discipline-Specific Responsibilities:

Process Engineering

• Lead small-scale continuous improvement projects in manufacturing operations.
• Drive measurable improvements in quality, material control, throughput, flexibility, and cost.
• Apply Lean tools and methods in problem-solving and process optimization.
• Conduct cycle time studies, line balancing, and assist in design of experiments using statistical approaches.
• Develop data collection tools and support KPI tracking for improvement projects.
• Support manufacturing engineers in implementing supervisory-level control solutions.

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