Job Details

Job Summary

The Manufacturing Engineer II supports the design, development, and improvement of manufacturing processes. This role is responsible for creating and maintaining key manufacturing documentation such as PFMEAs, process flow diagrams, manufacturing cell and line layouts, process routers, equipment qualifications, validation protocols, and work instructions. The engineer works cross-functionally to transfer products into production and support ongoing manufacturing operations. This role also helps implement lean manufacturing practices to improve efficiency, quality, and continuous improvement.

Duties and Responsibilities

• Design and develop manufacturing processes, select equipment, create work instructions, perform process validations (IQ/OQ/PQ), and train production staff.
• Develop, validate, and implement automated, semi-automated, and manual assembly and test equipment for disposable product manufacturing, ensuring proper documentation, calibration, and preventive maintenance.
• Participate in FMEA activities to identify and mitigate process risks.
• Collaborate with Design Engineering and Quality teams to ensure products are designed for manufacturability while meeting cost, quality, and performance requirements.
• Work with Quality and R&D to maintain compliance with internal quality systems and regulatory standards including FDA GMP, QSR, and ISO 13485.
• Support pilot production and develop lean manufacturing cells to improve throughput and product quality.
• Assist production teams by ensuring operators are trained, schedules are followed, and production documentation is accurate. Identify opportunities for process improvement.
• Continuously improve manufacturing processes related to safety, quality, lead time, productivity, and cost.
• Investigate manufacturing issues using NCMR and CAPA systems, determine root causes, and implement corrective and preventive actions.

Must Haves

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Mechanical Engineering Technology, or related field required.
• 5+ years of engineering experience
• 3+ years of medical device manufacturing
• Experience with 3D CAD software (SolidWorks preferred; AutoCAD or Pro/Engineer acceptable).
• Understanding of FDA GMP, QSR, and ISO 13485 requirements.

Nice to Haves

• Six Sigma Black Belt certification is a plus.
• Lean Manufacturing certification is a plus.
• Knowledge of electromechanical component and assembly design and fabrication.