Senior Mechanical Engineer

DSJ Global; Boston (MA); On-site; USD 110,000 - 170,000; Full time

Job summary

DSJ Global is seeking a Senior Mechanical Engineer to lead medical device product development in the Boston area. You will guide projects from concept through verification and regulatory readiness, collaborating with clients and multidisciplinary engineering teams.

The ideal candidate has a Bachelor’s degree in Mechanical Engineering and 5+ years of regulated medical device experience, with SolidWorks, FDA design controls, ISO 13485/14971, and DHF expertise.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field.
• 5+ years of medical device product development experience.
• Strong mechanical design background with SolidWorks expertise.
• Experience with FDA design controls and regulated development.
• Knowledge of ISO 13485, ISO 14971, and IEC 60601.
• Experience with DHF documentation, verification testing, and risk management.
• Proficiency in GD&T and tolerance analysis.
• Knowledge of sterilization methods and validation testing.

Responsibilities

• Lead mechanical design and development activities for medical device programs.
• Serve as a technical lead and mentor for engineering team members.
• Manage client interactions, design reviews, project timelines, and deliverables.
• Develop mechanical concepts, mechanisms, packaging solutions, and precision components.
• Design products using injection molding, machining, casting, laser cutting, welding, extrusion, and additive manufacturing methods.
• Perform prototyping, root cause analysis, tolerance stack analysis, FEA, and design optimization.
• Lead Design History File (DHF) development and FDA design control activities.
• Plan and execute verification testing, test method development, validation, and DOE activities.
• Collaborate with electrical, software, systems, human factors, and industrial design teams.
• Support project scoping, business development efforts, and risk management activities.

Skills

Mechanical design

Leadership

Regulatory knowledge

Project management

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Job description

Join a leading product development and engineering team focused on creating innovative medical technologies that improve lives. This role offers the opportunity to lead complex product development programs, work directly with clients, and collaborate with multidisciplinary engineering teams to bring new medical devices from concept through verification and commercialization.

What You'll Do

• Lead mechanical design and product development activities for medical device programs.
• Serve as a technical lead and mentor for engineering team members.
• Manage client interactions, design reviews, project timelines, and deliverables.
• Develop mechanical concepts, mechanisms, packaging solutions, and precision components.
• Design products using injection molding, machining, casting, laser cutting, welding, extrusion, and additive manufacturing methods.
• Perform prototyping, root cause analysis, tolerance stack analysis, FEA, and design optimization.
• Lead Design History File (DHF) development and FDA design control activities.
• Plan and execute verification testing, test method development, validation, and DOE activities.
• Collaborate with electrical, software, systems, human factors, and industrial design teams.
• Support project scoping, business development efforts, and risk management activities.

What You'll Bring

• Bachelor's degree in Mechanical Engineering or related field.
• 5+ years of medical device product development experience.
• Strong mechanical design background with SolidWorks expertise.
• Experience with FDA design controls and regulated product development.
• Working knowledge of ISO 13485, ISO 14971, and IEC 60601.
• Experience with DHF documentation, verification testing, and risk management.
• Proficiency in GD&T, tolerance analysis, and engineering documentation.
• Knowledge of sterilization methods, biocompatibility, sterile packaging, and validation testing.
• Experience within Neurology, Cardiovascular, Orthopedics, Women's Health, Diabetes, or related medical device markets preferred.