Senior Manufacturing Engineer - Judge Group

Location: Marlborough, MA
Salary: $130,000.00 USD Annually - $145,000.00 USD Annually
Description:

The Judge Group is seeking a Senior Manufacturing Engineer for a full time opportunity in Marlborough, MA.

• *Must have prior experience working with COMPLEX SINGLE USE Medical Disposables*
• Ideally with a background in prior Urethra or Endoscopy type medical devices
• Must have Medical Device experience

Job Title: Senior Manufacturing Engineer - Medical Device

Type: Full Time Direct Hire

Location: Marlborough, MA

Position Overview:

We are seeking a Manufacturing Process Engineer to oversee the manufacturing processes within a company operated under ISO 13485. This role involves setting up processes for complex medical instruments, from design input through verification, validation, and manufacturing transfer stages. The Engineer will ensure compliance with global regulatory requirements and optimize manufacturing costs.

Key Responsibilities:

• Manage manufacturing processes within an ISO 13485-operated company

• Set up and maintain manufacturing processes for complex medical instruments through all development phases

• Assist in developing product specifications for design for manufacturing and service in coordination with other departments

• Coordinate the technical transfer of products and instruments from development to manufacturing, including analysis of customer complaints and recommendations

• Optimize manufacturing costs for medical devices and instruments

• Ensure products meet stringent global regulatory requirements (e.g., FDA regulations, ISO 13485, CE mark)

• Develop and maintain design history files, PFMEA, and other documentation to support regulatory approval and manufacturing

Qualifications:

• Education:

  • Bachelor’s degree in Electrical or Mechanical Engineering

  • Strong knowledge of US and global regulatory requirements for medical devices

  • Solid project management skills

• Experience:

  • 10+ years of work experience in a fast-paced medical device manufacturing environment, including capital equipment and disposable instruments

  • Thorough approach to developing manufacturing processes for multi-functional medical instruments (mechanical, optical, electronic, fluid control components)

  • Experience coordinating development and operations teams, managing multiple suppliers, and adhering to strict schedules and budget boundaries

  • Knowledge of modern lean manufacturing practices and MRP/ERP systems

  • Experience in verification and validation of special manufacturing processes (e.g., laser welding, sterilization, packaging)

  • Experience implementing full or semi-automated production processes

Contact: amassad@judge.com