Senior Mechanical Engineer

Senior Mechanical Engineer - Permanent - Boston, US

Lead the development of cutting-edge medical device platforms that transform blood management and patient outcomes.

Proclinical is seeking a Senior Mechanical Engineer to join a dynamic research and development team in the US.

Primary Responsibilities:

The successful candidate will focus on designing, developing, and maintaining advanced medical device platforms that support blood management in healthcare. You will play a pivotal role as both a technical leader and hands-on engineer, contributing to the creation of innovative, reliable, and cost-effective solutions.

Skills & Requirements:

• Degree in Mechanical Engineering (BSME or MSME) with experience in mechanical product design for complex electromechanical systems, preferably in the medical device or high-reliability industries (e.g., automotive, aerospace).
• Expertise in mechanical engineering disciplines, including plastics, metals, materials, thermal management, and reliability engineering.
• Proven experience designing electromechanical medical devices from concept to production, including next-generation platform development.
• Proficiency in Solid Works 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-ISO 60601, IEC 61010) and experience supporting compliance activities.
• Hands-on experience with manufacturing operations, including line layout, fixturing, and inline testing strategies.
• Demonstrated success in delivering complete electromechanical platform products from concept to production.

Preferred:

• Experience with third-party lab testing, simulation analysis, and certification for IEC safety and EMC compliance.
• Knowledge of motor systems, motion control, pneumatic systems, fluid-handling mechanisms, and thermal dynamics.
• Familiarity with manufacturing processes, including cables, shielding, and system-level electromechanical integration.
• Experience driving continuous improvement initiatives to enhance design efficiency and manufacturability.

The Senior Mechanical Engineers responsibilities will be:

• Design, develop, and maintain medical devices for blood component separation, including therapeutic treatments, transfusions, and diagnostics.
• Serve as a technical leader across engineering disciplines, including material selection, thermal management, electromechanical mechanisms, and compliance with medical standards (e.g., IEC-ISO 60601, IVD 61010).
• 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 (e.g., design for manufacturing, reliability, and serviceability).
• Investigate and resolve product failures, using root cause analysis and DOE methods to implement solutions.