Sr. Optical-Mechanical Engineering Manager

Kaye/Bassman International; Boston (MA); On-site; USD 170,000 - 210,000; Full time

Job summary

Kaye/Bassman International is seeking a Sr. Optical-Mechanical Engineering Manager for a growing medical device company near Boston.

You will be the technical anchor of the mechanical engineering organization, balancing hands-on design leadership with coaching a team of engineers and technicians. You will guide complex optical-mechanical systems from design input through verification and validation to manufacturing transfer, ensuring compliance with FDA, ISO 13485 and CE marking requirements,

Qualifications

• Minimum of 15 years of experience in design and packaging of systems and devices.
• At least 10 years in the medical device industry with 5 years leading an engineering team.
• Experience with optical devices, coatings, geometrical optics, and troubleshooting.

Responsibilities

• Manage the Mechanical Engineering group.
• Serve as a technical lead and mentor to staff from Technicians to Senior Engineers.
• Lead development of complex medical devices through all development phases—from design input to verification/validation and manufacturing transfer.

Skills

Optical engineering

Mechanical design

Team leadership

SolidWorks

Thermal management

Tolerance analysis

Regulatory compliance

DFMEA

Regulatory compliance (FDA/ISO)

Education

BSME

MSME preferred

Tools

Zemax

Job description

My client is a growing medical device company at the forefront of laser-based precision technologies that directly improve patient care. They are seeking a Sr. Optical-Mechanical Engineering Manager to serve as the technical anchor of the mechanical engineering organization. This is a true player-coach role: you will drive design and engineering decisions on complex optical-mechanical systems while managing and mentoring a team ranging from Engineering Technicians to Senior Engineers.

As a manager, this role requires a demonstrated ability to lead and develop a team of engineers, balance resources and capabilities, and mentor team members as they develop.

• Manage the Mechanical Engineering group.
• Serve as a technical lead and mentor to Mechanical Engineering staff ranging from Engineering Technicians to Senior Engineers.
• Lead development of complex medical devices and subsystems through all development phases from design input through verification and validation to manufacturing transfer stages and in coordination with overall system 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
• Assure products are designed to meet stringent global medical device regulatory requirements, such as FDA regulations, ISO 13485, CE marking, and others.

Requirements:

• Minimum of BSME, MSME preferred
• Minimum of 15 years of experience in the design and packaging of systems and devices.
• At least 10 years of experience in the medical device industry and 5 years of experience managing or leading an engineering team are required.
• Experience with mid-power laser-powered systems, disposable surgical fibers, and thermal management is desirable.
• At least 5 years of experience leading the development of optical devices, including knowledge of optical materials, coatings, basic geometric optics, and troubleshooting optical systems.
• Proficiency in SolidWorks, including opto-mechanical design, incorporation of Zemax designs into hardware, and thermal management.
• Complete understanding of tolerance analysis and engineering drawing methods.
• Comprehensive knowledge of fabrication processes for optical sub-systems, including emerging and innovative manufacturing techniques such as laser-sintered metals.