Staff Mechanical Engineer
Location: Massachusetts Hybrid
Sector: Medical Technology / Biotechnology / Engineering Innovation
Overview
Our client is seeking a Staff Mechanical Engineer to join a high-performing engineering team driving innovation in next-generation medical and technology products. This role offers the opportunity to take ownership of complex system and component designs, lead cross-functional collaboration, and ensure products meet the highest standards of quality, performance, and compliance.
You will play a key role in advancing mechanical system development, guiding design strategy, mentoring engineers, and helping shape the future of cutting-edge devices and systems.
Key Responsibilities
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Lead the development of complex mechanical systems, components, and assemblies from concept through to production.
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Drive design excellence by applying deep technical expertise, creative problem-solving, and a thorough understanding of advanced mechanical principles.
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Own the creation of hardware requirement documents, technical specifications, and detailed drawings.
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Ensure all designs meet cost, performance, reliability, and quality targets — delivered on time and within budget.
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Collaborate with cross-functional teams including quality, manufacturing, regulatory, and product management to ensure seamless project execution.
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Conduct tolerance analysis, structural and thermal analysis, FEA/CFD simulations, and validation testing.
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Lead risk management, failure analysis, and root cause investigations for complex technical issues.
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Partner with manufacturing and suppliers to ensure designs meet manufacturability, safety, and regulatory standards.
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Provide mentorship and technical leadership to junior engineers and cross-functional project teams.
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Support and present technical documentation for design and phase-gate reviews.
Qualifications & Experience
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Bachelor’s degree in Mechanical, Biomedical, or related Engineering discipline (Master’s preferred).
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8+ years of relevant mechanical engineering experience within medical device, biotechnology, or advanced technology industries.
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Strong understanding of system architecture design, regulatory standards (FDA QSR, ISO 13485, ISO 60601, ISO 14971), and QMS processes.
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Expertise in SolidWorks, tolerance analysis, and both plastic and metal component design (including injection molding, die casting, and machining).
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Proven ability to design for manufacturability and take products through the full lifecycle — from concept to production.
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Strong analytical background in structural, thermal, and fluid dynamics.
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Experienced in FEA, CFD, and prototype testing.
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Excellent communication and leadership skills, with the ability to collaborate effectively across diverse technical and commercial teams.
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Passion for improving healthcare through innovative mechanical design and technology.
Why Apply Through NexGen Search?
At NexGen Search, we connect forward-thinking professionals with organisations that are redefining the future of healthcare and technology. We specialise in roles that bridge innovation, science, and human impact—helping you find opportunities where your work truly matters.
If you’re passionate about advancing patient-centric design and driving meaningful change in healthcare, we’d love to hear from you.