Senior Mechanical Engineer / Senior Mechanical Engineeress

Senior Mechanical Engineer - Permanent - Boston, US

Join a dynamic research and development team at Proclinical and lead the development of cutting-edge medical device platforms that transform blood management and enhance patient outcomes. We are seeking a skilled Senior Mechanical Engineer to play a pivotal role in designing, developing, and maintaining advanced medical device platforms in healthcare.

Primary Responsibilities

The successful candidate will:

• 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.

Skills & Requirements

The ideal candidate should possess the following qualifications:

• 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 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-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 Qualifications

• 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.

If you are interested in this exciting opportunity, please apply online using the form below. Only applications matching the job profile will be considered.

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