Senior Mechanical Engineering Manager, Medical Devices

Kaye/Bassman International; Boston (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

Kaye/Bassman International presents a Senior Mechanical Engineering Manager for a forward‑looking medical device company. You will lead development of complex medical devices and subsystems from design input through verification, validation, and transfer to manufacturing, coordinating with system requirements.

Responsibilities include developing product specifications with marketing and customers, transferring designs to production, driving cost‑reduction programs, and ensuring compliance with

Qualifications

• BS in Mechanical Engineering; MS preferred.
• 10 years in Mechanical Design Engineering in Medical Device Industry.
• Experience leading multi-disciplinary development teams.
• Strong knowledge of FDA, ISO 13485 and CE medical device requirements.
• Experience with ISO 13485, FDA protocols across design input to production.
• Proficiency with 3D design tools (SOLIDWORKS) and PDM systems.
• Ability to manage regulatory documentation (DHFs).

Responsibilities

• Lead development of complex medical devices and subsystems from design input to manufacturing transfer.
• Develop product specifications with marketing, customers, and other departments.
• Coordinate transfer of products to customers or distributors; analyze complaints.
• Develop cost-reduction programs for medical instruments.
• Ensure designs meet FDA, ISO 13485, CE and other regulatory requirements.
• Maintain design history files and documentation for regulatory approval.
• Travel (<10%) to interface with domestic partners and regional facilities.

Skills

Project management

Leadership

Regulatory compliance

Mechanical design

Cross-functional collaboration

Travel readiness

Education

BS in Mechanical Engineering

MS in Mechanical Engineering

Tools

SOLIDWORKS

PDM systems

3D CAD

Job description

Kaye/Bassman International presents a Senior Mechanical Engineering Manager for a forward‑looking medical device company. You will lead development of complex medical devices and subsystems from design input through verification, validation, and transfer to manufacturing, coordinating with system requirements.

Responsibilities include developing product specifications with marketing and customers, transferring designs to production, driving cost‑reduction programs, and ensuring compliance with