Senior Manufacturing Engineer-Medical Device

The Senior Manufacturing Engineer will support a new product launch within a regulated manufacturing environment. This role focuses on hands‑on production floor support, process troubleshooting, and continuous improvement initiatives. The position works closely with operations, technicians, and cross‑functional teams to enhance safety, quality, delivery, and cost performance. This is an opportunity to contribute to state‑of‑the‑art products while driving operational excellence.

• Provide front‑line manufacturing engineering support in a clean room production environment
• Support new product introductions, equipment implementation, process improvements, and cost reduction initiatives
• Coach and support assemblers and technicians through daily production activities and training certifications
• Instruct production personnel on manufacturing and testing procedures for medical devices
• Recommend and implement improvements to processes, tooling, and equipment to enhance safety, quality, and productivity
• Troubleshoot daily safety, quality, and process issues on the manufacturing floor
• Analyze test data, interpret product performance trends, and support yield improvement activities
• Perform scrap analysis and lead root cause investigations for nonconformances
• Communicate manufacturing performance, issues, and resolutions across shifts and with leadership and cross‑functional teams
• Ensure compliance with quality systems, environmental systems, and applicable regulatory requirements

• Bachelor of Science or Bachelor of Engineering in Electrical, Mechanical, Biomedical Engineering, or a related discipline
• Minimum five years of experience in manufacturing engineering, production support, or a related technical role
• Strong understanding of manufacturing processes and the ability to operate manufacturing equipment
• Hands‑on experience with root cause analysis and structured problem‑solving techniques
• Experience working cross‑functionally in a regulated manufacturing environment
• Strong communication, organization, and collaboration skills
• Ability to work independently, take ownership of complex issues, and support production floor activities

• Experience in the medical device industry, particularly Class Two or Class Three products
• Exposure to lean manufacturing principles and continuous improvement methodologies
• Experience supporting production floor operations during product launches or volume ramp‑ups

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long‑term disability insurance, short‑term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.