Manufacturing Engineer

The Manufacturing Engineer II supports medical device manufacturing operations in a fast-paced, regulated environment. This role focuses heavily on engineering documentation, manufacturing line support, and cross-functional collaboration with R&D, Operations, and Production teams. The ideal candidate has strong attention to detail, experience in regulated industries, and the ability to execute projects on aggressive timelines.

• Provide manufacturing engineering support for medical device production
• Develop and execute project plans to meet aggressive manufacturing timelines
• Support manufacturing line setup, including fixtures, tools, and equipment in cleanroom environments
• Perform line support and troubleshooting; provide technical guidance to technicians and operators
• Create, review, and maintain engineering documentation including protocols, reports, and engineering change orders (ECOs)
• Manage and route documentation through Windchill or similar document control systems
• Participate in cross-functional meetings with R&D, Operations, Production, and Commercial teams
• Ensure compliance with FDA regulations and internal quality systems
• Balance hands-on manufacturing floor support with desk-based documentation activities

• Bachelor’s degree in Engineering or a related scientific discipline
• Minimum 2 years of relevant industry experience
• Strong experience with engineering documentation in regulated environments
• Experience using Windchill or comparable PLM/document control systems
• Excellent written and verbal communication skills
• Strong attention to detail and organizational skills

• Medical device manufacturing experience
• CAD experience (Solid Works, Creo)
• Experience with manufacturing line setup, builds, and equipment qualification
• Knowledge of delivery systems and shaft-based products
• Understanding of FDA regulations (21 CFR 820)
• Experience with IQ/OQ/PQ process validation
• Basic knowledge of statistics and data analysis

• Preferred: 2–5 years of manufacturing or process engineering experience
• Master’s degree accepted with 1–3 years of experience
• Candidates with more than 7 years of experience are not preferred