Manufacturing Engineer

Position Summary

The Manufacturing Engineer plays a key role in ensuring the manufacturability and testability of Class III implantable neuromodulation systems. This role is responsible for developing, qualifying, and sustaining manufacturing processes, equipment, and tooling to support efficient, compliant, and scalable production. The Manufacturing Engineer partners closely with Quality, Supply Chain, and Operations to drive process capability, yields, and continuous improvement in a regulated medical device environment.

Essential Functions

• Evaluate and optimize production equipment and manufacturing processes to support quality, capacity, cycle time, and cost objectives
• Lead the acquisition, installation, and qualification of production equipment and tooling, including authorship and execution of IQ, OQ, and PQ documentation
• Lead and support manufacturing process improvements to enhance manufacturability, quality, labor efficiency, and throughput
• Apply structured problem-solving and continuous improvement methodologies (e.g., Value Stream Mapping, 5S, DMAIC)
• Manage and maintain Manufacturing Procedures (MPs) through established change control and engineering change processes
• Drive and participate in regular production meetings to monitor manufacturing performance metrics, including first-pass yield, scrap rate, and nonconformance trends
• Utilize statistical and quality tools such as Gage R&R, Cp/Cpk, and SPC to assess and improve process capability and reduce variation
• Partner with Quality to investigate and resolve manufacturing nonconformances, deviations, and customer complaints
• Support supplier interactions related to manufacturing readiness, component quality, and process capability
• Support manufacturing transfers, scale-up activities, and new product introductions
• Ensure manufacturing activities comply with FDA regulations, ISO 13485 requirements, and internal Quality Management System (QMS) procedures
• Adhere to Environmental, Health, and Safety (EHS) requirements and promote safe and environmentally responsible work practices

Qualifications

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or related field required
• Minimum of three (3) years of experience in the medical device industry, preferably supporting manufacturing and/or active implantable medical devices required
• Strong working knowledge of ISO 13485 and U.S. FDA Quality System Regulations required
• Demonstrated experience leading engineering projects using structured project management approaches required
• Experience managing and collaborating with component suppliers required
• Prior experience supporting manufacturing transfers or production scale-up activities required
• Strong electro-mechanical design, manufacturing, and analysis skills required
• Excellent analytical, problem-solving, and decision-making capabilities required
• Strong organizational skills with high attention to detail and adaptability in a fast-paced environment required
• Master’s degree in engineering preferred
• Experience with SolidWorks or similar CAD tools preferred
• Six Sigma certification (Green Belt or above) preferred

Physical Demands

• Ability to use standard hand tools used in the assembly of medical devices
• Climb or balance
• Sit
• Kneel, crouch, or crawl
• Lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.