Senior Mechanical Engineer - Medical Devices

Proclinical Staffing; Boston (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

Proclinical Staffing seeks a Senior Mechanical Engineer to lead the development of advanced medical device platforms for blood management in healthcare. You will be a technical leader and hands-on engineer driving concept-to-production efforts.

The role focuses on designing, developing, and maintaining electromechanical medical devices, with emphasis on DFM/DFA, regulatory compliance, and collaboration with design partners to meet UX and mechanical requirements.

Qualifications

• BSME or MSME with experience in mechanical product design for complex electromechanical systems, preferably medical devices.
• Expertise in plastics, metals, materials, thermal management, and reliability engineering.
• Experience designing electromechanical medical devices from concept to production, including next-generation platform development.
• Proficiency in SolidWorks for complex assemblies, drawings, and PDM, with strong skills in 2D/3D CAD design, simulations, and tolerance analysis.
• Experience executing full product development cycles, including prototype phases and transitioning designs to manufacturing.
• Strong application of DFM/DFA principles and collaboration with industrial design partners to meet UX and mechanical requirements.
• Familiarity with medical device regulatory standards (e.g., IEC-60601, IEC 61010) and experience supporting compliance activities.

Responsibilities

• Design, develop, and maintain medical devices for blood component separation, including therapeutic treatments, transfusions, and diagnostics.
• Lead cross-functional teams through design control processes, from product requirements to release, ensuring customer needs are met.
• Collaborate with suppliers on materials selection, quality specifications, troubleshooting, and capability analysis.
• Translate customer and user requirements into reliable, low-cost product designs, successfully launching products to market.
• Conduct GDT assembly or component tolerance analysis and build mechanical prototypes to validate design feasibility and performance.
• Document all design phases, including requirements, specifications, test procedures, and reports, while adhering to DFX principles.
• Investigate and resolve product failures, using root cause analysis and DOE methods to implement solutions.

Skills

Mechanical design

Thermal management

DFM/DFA

SolidWorks

Electromechanical systems

Regulatory knowledge IEC 60601

Manufacturing collaboration

Prototype development

Education

BSME or MSME

Tools

SolidWorks

Job description

Proclinical Staffing seeks a Senior Mechanical Engineer to lead the development of advanced medical device platforms for blood management in healthcare. You will be a technical leader and hands-on engineer driving concept-to-production efforts.

The role focuses on designing, developing, and maintaining electromechanical medical devices, with emphasis on DFM/DFA, regulatory compliance, and collaboration with design partners to meet UX and mechanical requirements.