Mechanical Engineer - Medical Device (Bedford, MA)

Job Title Mechanical Engineer - Medical Device (Bedford, MA) Job Description Mechanical Engineer – Medical Imaging (Bedford, MA) The Mechanical Engineer drives innovation in medical imaging hardware, initiating novel designs from the ground up and leveraging advanced technologies and creative engineering approaches to address unmet clinical and user needs, working under limited supervision. The role collaborates on project-wide verification reviews, ensuring comprehensive system and sub-system coverage while implementing designs that exceed product specifications, regulatory requirements, and international standards. With a user-centered design mindset, the engineer considers clinical workflows, usability, serviceability, and real-world operating conditions when developing and improving hardware solutions. Through rigorous review of prototypes, specifications, and test equipment, the engineer refines design concepts and champions breakthrough ideas that bring new medical imaging products to market and set new benchmarks for quality, performance, and patient impact.  This is a full-time, primarily on-site role based in Bedford, Massachusetts.

Designs and implements hardware solutions that meet or exceed medical imaging product specifications, applicable regulatory requirements (FDA, IEC 60601, IEC 62304, ISO 14971), and international standards.  Creates and evaluates prototypes, specifications, and test equipment/fixtures to prove design concepts, identify performance gaps, and implement improvements to hardware design, verification strategy, and test methods.  Collaborate on project-wide verification reviews across system and sub-system levels for medical imaging hardware, identifying gaps, eliminating redundant testing, and improving traceability between requirements and verification evidence.  Champions a culture of innovation and experimentation, encouraging exploration of new designs, verification methodologies, test automation, and tools to improve efficiency and coverage.  Works collaboratively with engineering, regulatory, quality, clinical, and program management teams to facilitate open dialogue and shared decision-making during the design and development of new medical imaging products. This cross-functional approach ensures verification progress, potential risks, and design choices are transparently communicated and understood throughout the product lifecycle.  Analyzes verification data and test results to identify trends, root causes, and opportunities for design or process improvement across medical imaging hardware platforms.  Contributes to risk management activities for medical imaging hardware by identifying key failure modes and supporting practical design mitigations that enhance patient and product safety.  You're the right fit if: You bring a minimum of 2 years of relevant industry experience as an individual contributor, ideally within medical devices or another highly regulated industry such as aerospace. Familiarity with mechanical safety and regulatory compliance standards (such as ISO 13485 and IEC 60601-1) are a plus.  You have strong mechanical engineering skills, including proficiency in 3D modeling and design using SolidWorks, a solid grounding in mechanical engineering theory and analytical problem solving. Bonus: experience with additive manufacturing (3D printing), subtractive manufacturing (CNC machining), rapid prototyping, finite element analysis (FEA), materials selection, and transition-to-manufacturing activities.  You hold a Bachelor’s or Master’s degree in Mechanical Engineering or a closely related technical field.  You are comfortable working in a regulated environment, collaborating cross-functionally, and supporting designs through development, verification, and manufacturing, with a focus on quality, reliability, and compliance.  You must be able to successfully perform the following minimum Physical, Cognitive and