Description

You will lead the design and development of product changes within sustaining engineering for disposable medical devices.

Responsibilities

• Lead engineering projects, including scheduling and budgeting, with minimal guidance.
• Serve as the technical expert for design change programs, covering new products, suppliers, materials, labeling, CAPA/NCR, cost reduction, and remediation.
• Identify and solve complex engineering problems using dFMEA, Human Factors Engineering, and statistical software.
• Own the creation and maintenance of Design History Files (DHF) and adhere to design control procedures.
• Coordinate R&D efforts with global cross-functional stakeholders and support manufacturing plant operations.

Required Skills

• 8+ years of experience in Class II or Class III disposable medical product development.
• Advanced knowledge of plastics materials and processing, including injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
• Deep understanding of FDA Design Controls and ISO 13485 Quality Management Systems.
• Proficiency with CAD design and PDM enterprise software, specifically Creo and Solidworks.
• Working knowledge of ANSI/AAMI/ISO 14971 Risk Management.
• Proven experience in design transfer from R&D to manufacturing.
• Strong background in product assembly processes and change control.
• Bachelor's degree in Mechanical, Plastics, or Biomedical Engineering.

Preferred Skills

• Master's degree in a related engineering field.
• Experience with MDR (Medical Device Regulation) and remediation projects.

Key Skills

Education

Bachelor's degree