Senior Mechanical Engineer – Electromechanical Platform Architecture

About the role

We are looking for a highly motivated Senior Mechanical Design Engineer to join our R&D team. This role is located at 125 Summer Street, Boston, MA, just a 5-minute walk from South Station.

Responsibilities

• Design, develop, and maintain medical device platforms that separate blood components (e.g. apheresis devices) for therapeutic treatments, blood transfusions, pharmaceutical industry, and diagnostic equipment to support the healthcare blood management industry.
• Technical Leader in a wide range of engineering disciplines including material selections, thermal management, electromechanical, mechanisms, safety medical standards (IEC/ISO 60601 standard series, IVD 61010 standard series, etc.) compliance, design for reliability and planning, mechanical verification, and etc.
• Lead cross-functional technical team discussions following our design control process from product requirements, designs, verification, and product release while meeting our customers demanding requirements.
• Lead technical discussions with key component suppliers in the areas of materials selection, critical to quality specifications, trouble shooting, DOE capability, etc.
• Demonstrated technical development success in translating Customer/User requirements/needs into reliable low-cost product designs and launch products to market successfully.
• GD&T & assembly or component tolerance analysis is a MUST.
• Design & build mechanical prototypes and prove design feasibility, functionality, and performance.
• Document all phases of the design including requirements, specifications, plans, reviews, test procedures, test reports, and various DFX disciplines (e.g., design for manufacturing, design for reliability, design for serviceability.)
• Lead existing product failure investigations: Investigate and determine root cause of product issues and use DOE method to implement solutions.

Requirements

• BSME / MSME with 7+ years experience in Mechanical product design of complex electro-mechanical products in the medical device industry (or equivalent high reliability industries such as automotive, aerospace, military, etc.).
• Deep technical expertise across mechanical engineering disciplines, including plastics, metals, materials, thermal management, mechanisms, and reliability engineering.
• Proven experience designing electromechanical medical devices from concept through production, including next-generation platform development.
• Strong device architecture, subassembly placement, UX considerations, heat distribution, design for serviceability, and design for manufacturing.
• Extensive hands-on expertise with SolidWorks (Complex assemblies, drawings, and PDM); SolidWorks proficiency is mandatory.
• Experience executing full product development and prototype phases (LP, PP, PPQ) and transitioning designs to manufacturing.
• Strong application of DFM/DFA principles throughout development phases.
• Experience working closely with industrial design partners to translate UX requirements into robust mechanical solutions.
• Solid documentation capability, including system requirements, theory of operation, CAD drawings, test protocols and reports, risk analysis, and failure analysis.
• Solid understanding of medical device regulatory requirements and standards (e.g., IEC/ISO 60601, IEC 61010), with experience supporting compliance activities and regulatory submissions.
• Experience supporting manufacturing operations, including line layout, fixturing, kanban subassemblies, in-line testing, and final device test strategies.
• Demonstrated delivery of at least 1–2 complete electromechanical platform products from concept to production (medical device experience strongly preferred).

Preferred Experience

• With third-party lab testing, simulation analysis, and certification for IEC safety and EMC compliance.
• Knowledge of motor systems, motion control, and rotating machinery.
• Knowledge of pneumatic systems, fluid-handling mechanisms, and thermal dynamics.
• Broad familiarity with manufacturing processes including cables, shielding, and system-level electromechanical integration.