Mechanical Engineer in Foxborough

Job DescriptionJob Description

Position Overview

A growing medical device organization is seeking a skilled mechanical engineer to support the design, development, testing, and optimization of innovative medical device products. This role is fully onsite and collaborative in nature, working cross-functionally with engineering, quality, operations, supply chain, and leadership teams across the full product development lifecycle — from early concept and prototyping through validation and manufacturing readiness.

Key Responsibilities

• Design and develop mechanical components, subsystems, and complete medical device assemblies
• Create and maintain detailed 3D models, engineering drawings, and product specifications using SolidWorks
• Plan, execute, and document characterization, verification, and environmental testing activities
• Develop test protocols and generate comprehensive test reports in support of product validation
• Collaborate with suppliers to source, evaluate, and qualify components, tooling, and manufacturing processes
• Partner with operations and quality teams to ensure products meet design and manufacturability requirements
• Translate customer and project requirements into engineering solutions and deliverable milestones
• Participate in cross-functional design reviews and technical discussions to identify and resolve design challenges
• Prepare and maintain product development documentation in compliance with customer, regulatory, and quality requirements
• Identify and mitigate risks related to product performance, reliability, safety, cost, and scalability
• Support continuous improvement efforts related to product design, manufacturing processes, and engineering best practices

Qualifications

Required:

• Bachelor's degree in Mechanical Engineering or a related engineering discipline
• 5+ years of product design and development experience
• Proficiency in SolidWorks CAD software
• Experience leading or contributing to new product development programs
• Knowledge of manufacturing processes including injection molding, metal forming, welding, and mechanical assembly
• Experience designing products for manufacturability and automation
• Working knowledge of FDA Quality System Regulations (QSR) and ISO 13485 Design Controls
• Strong project management, organizational, and problem-solving capabilities
• Proficiency in Microsoft Office and Microsoft Project
• Excellent written and verbal communication skills
• Ability to work independently and manage multiple priorities in a fast-paced environment

:

• Master's degree in Engineering or a related field
• 7+ years of medical device engineering experience
• Experience working within FDA-regulated and ISO 13485-certified manufacturing environments
• SolidWorks Expert Design Certification
• Background in electro-mechanical systems, instrumentation, robotics, or automation technologies

Work Environment & Schedule

• Professional office, laboratory, and cleanroom setting
• Collaborative, team-oriented culture with broad cross-functional exposure
• Business casual dress code
• Standard hours: Monday – Friday, 8:00 AM – 5:00 PM
• Full-time onsite attendance required
• Occasional travel to customer sites may be needed
• No direct supervisory responsibilities; project-level guidance may be provided as needed

Physical Requirements

• Ability to work at a computer for extended periods
• Full wrist, hand, and finger dexterity required for engineering and laboratory tasks
• Comfortable working in engineering lab and cleanroom environments

Equal Opportunity Statement

This employer is committed to building a diverse and inclusive workplace. All qualified applicants will be considered without regard to , , , , , , , , , veteran status, or any other characteristic protected under applicable federal, state, or local law.