Sr Mechanical Engineer

G&H Staffing Companies (Temp-Secure Staffing and LSE Staffing); Westborough (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Our client is seeking a Senior Mechanical Engineer to lead the design of complex medical devices on-site in Massachusetts. You will guide development through design input, verification and validation, ensuring compliance with FDA, ISO 13485, and CE marking requirements.

Responsibilities include developing product specifications with cross-functional teams, maintaining design history files, and applying innovative approaches to multi-functional instruments involving mechanical, optical, and

Qualifications

• Bachelor's degree in Engineering required.
• 8+ years of mechanical design experience in medical devices.
• Experience with FDA/ISO 13485 regulatory contexts.
• Strong project management and leadership skills.
• Experience with SOLIDWORKS and PDM.

Responsibilities

• Lead development of complex medical devices from design input through verification and validation.
• Ensure designs meet regulatory requirements (FDA, ISO 13485, CE).
• Develop and maintain design history files and related documentation.
• Coordinate product specifications with marketing, customers and other departments.

Skills

Project leadership

Medical device design

3D design

Breadboarding prototyping

Leadership

Education

Bachelor's degree in Engineering

Tools

SOLIDWORKS

PDM system

Job description

Our client is looking to bring on a SR Mechanical Engineer. This is a direct hire opportunity on-site.

Responsibilities:

• Lead development of complex medical devices and subsystems through all development phases from design input through verification and validation.
• Assure products are designed to meet stringent global regulatory requirements of medical devices, such as FDA regulations, ISO 13485, CE mark for medical product and others;
• Assist in development and maintaining of design history file and other documentation to support product regulatory approval and manufacture.
• Develop product specification in coordination with marketing, customers and other company departments.

Experience:

• Bachelors degree in Engineering is a must have
• 8+ years of Mechanical Design Engineering experience.
• Experience working in the medical device industry.
• Strong project management & leadership skills and experience.
• Innovative approach in development of multi-functional medical instruments including mechanical / optical / electronic components and lab experimentation with breadboards.
• Experience with a 3D design tool, preferably SOLIDWORKS including PDM system