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

My client is an innovative medical device organization developing next-generation healthcare technologies designed to improve patient outcomes. My client is advancing precision medical solutions through cutting-edge engineering, laser-based technology, and a strong commitment to quality and continuous innovation. Their collaborative, high-performance environment empowers teams to push boundaries and deliver meaningful impact in patient care.

This is an opportunity to join a forward-thinking organization where innovation meets purpose and to play a key role in shaping the future of medical technology.

Position:

The Senior Mechanical Engineering Manager will lead development of complex medical devices and subsystems through all development phases, from design input through verification and validation to manufacturing transfer stages, in coordination with overall system requirements.

Responsibilities:

• Assist in developing an IP portfolio for these instruments and provide original technical solutions to improve performance, functionality, reliability, and cost requirements.
• Develop product specifications in coordination with marketing, customers, and other company departments.
• Coordinate the technical part of the transfer of company products and instruments to customers or distributors, including analysis of customer complaints and recommendations.
• Develop a cost-reduction program for medical instruments.
• Ensure product designs meet stringent global regulatory requirements for medical devices, including FDA regulations, ISO 13485, the CE mark for medical devices, and other requirements.
• Assist in the development and maintenance of the design history file and other documentation to support product regulatory approval and manufacture.
• Requires some travel to interface with the domestic partner and regional facilities (<10%)

Requirements:

• BS in Mechanical Engineering, MS in Mechanical Engineering preferred
• Strong knowledge of the engineering aspects of US and global regulatory requirements for medical devices.
• Experience in research and development of Class II electro-mechanical medical devices.
• 10 years of Mechanical Design Engineering experience within the Medical Device Industry.
• 5 years in a senior position of supervising the technical part of development projects with internal and external teams.
• Experience with development partners and suppliers within a company operating under ISO 13485 and FDA protocol in all phases, from design input to transfer to production.
• Strong project management & leadership skills and experience.
• Experience with a 3D design tool, preferably SOLIDWORKS, including PDM systems.
• Demonstrated success in directing, coordinating, and executing all phases, including planning, organization, execution, integration, and completion of engineering projects.
• Strong working knowledge of device packaging, opto-mechanical, interfacing with systems and electronics groups, & automation systems

Preferred:

• Experience with thermal management of optical systems, including source cooling with air, fluid, and TECs.
• Experience with lasers and optics within the Medical Device Industry.
• Experience in the development of optical systems, including alignment, stability, packaging, tolerancing, and specifying optical components.