Manufacturing Engineer

Job Title:

Manufacturing Engineer Job Description

The Manufacturing Engineer leads sustaining and continuous improvement of equipment and processes for medical devices, working with minimal supervision and applying broad manufacturing and maintenance engineering principles. This role serves as the voice of engineering throughout the product life cycle and collaborates closely with Product Development, Operations, Supply Chain, and Quality Assurance to support ongoing production, drive process efficiency, and ensure product quality.

The engineer focuses on troubleshooting and debugging production lines and equipment, qualifying production lines and processes, reducing scrap, and supporting new product line onboarding in a fast-paced medical device manufacturing environment.

• Ensure production equipment and processes adhere to Quality Management System guidelines, standard operating procedures, applicable Federal Regulations, and International Standards while following good documentation practices.
• Work hands-on to develop system-level design strategies for manufacturing equipment and processes, make clear recommendations to leadership, and coordinate implementation of improvements focused on process optimization and efficiency gains.
• Support the design, development, testing, and refinement of systems and sub-systems used in the manufacture of medical device products.
• Own assigned manufacturing processes and partner with Operations to maximize line utilization, optimize material flow, improve efficiencies, and reduce scrap.
• Monitor and analyze production performance, identify opportunities for improvement, and report findings clearly and concisely, highlighting deviations and providing status updates and progress reviews.
• Lead and support production line qualification activities and process qualifications to ensure new and existing lines meet performance, quality, and regulatory requirements.
• Support equipment preventive maintenance and calibration activities to ensure production equipment operates at peak efficiency with minimal downtime.
• Rapidly and accurately determine root causes of equipment and process faults and product non-conformances, formulate recommendations, and implement effective corrective actions.
• Apply a broad knowledge of manufacturing and maintenance engineering principles, practices, and procedures to complete complex and open-ended assignments that require inventiveness and creativity.
• Contribute to onboarding of new product lines by supporting process development, equipment setup, and documentation of work instructions and operating procedures.
• Generate, follow, and explain detailed proposals and operating procedures, including assembly instructions, inspection procedures, maintenance schedules and guidelines, and technical proposals.
• Use strong analytical skills to develop mathematical solutions based on fundamental engineering principles to address production and process challenges.
• Collaborate cross-functionally with Product Development, Quality Engineers, Production, Supply Chain, and other stakeholders to ensure alignment on process changes and product requirements.
• Listen to and work with others to contribute new ideas that enhance product quality, process efficiency, and overall operations.
• Demonstrate a consistent commitment to quality and customer satisfaction for both internal and external customers, and maintain a high standard of ethics in all activities.

• Bachelor’s degree in Engineering, with preference for Mechanical Engineering or Manufacturing Technology.
• Recent, hands‑on experience working within the medical device industry.
• Proven experience analyzing and solving complex production issues in a manufacturing environment.
• Ability to…