3 часа назад
Senior Mechanical Engineer (Medical Devices)
90 100 - 153 300$
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Описание вакансии
Текст:
TL;DR
Senior Mechanical Engineer (Medical Devices): Designing and developing electromechanical medical device platforms for blood component separation from concept through production with an accent on device architecture, mechanical integration, reliability, and regulatory compliance. Focus on leading cross-functional design control activities, building and testing prototypes, analyzing tolerances, investigating failures, and transitioning robust designs to manufacturing.
Location: Boston, MA, US; full-time role based at 125 Summer Street
Base salary: $90,100–$153,300 annually, plus potential discretionary annual bonus and long-term incentives.
Company
designs and manufactures medical devices for blood component separation, therapeutic treatments, transfusions, pharmaceutical applications, and diagnostic equipment.
What you will do
- Design, develop, maintain, integrate, and test existing and next-generation electromechanical medical device platforms.
- Provide technical leadership across materials selection, thermal management, mechanisms, reliability, safety standards compliance, and mechanical verification.
- Lead cross-functional technical discussions throughout product requirements, design, verification, and product release.
- Collaborate with component suppliers on materials, critical-to-quality specifications, troubleshooting, and design of experiments.
- Build mechanical prototypes and document requirements, specifications, design reviews, test procedures, reports, and design-for-X activities.
- Investigate product failures, determine root causes, and implement solutions using design of experiments.
Requirements
- BSME or MSME with 7+ years of mechanical product design experience for complex electromechanical products in medical devices or another high-reliability industry.
- Deep expertise in plastics, metals, materials, thermal management, mechanisms, and reliability engineering.
- Experience designing electromechanical medical devices from concept through production and delivering complete platform products.
- Mandatory: extensive SolidWorks experience, including complex assemblies, drawings, and PDM.
- Experience with 2D/3D CAD, simulations, tolerance analysis, mechanical verification, DFM/DFA, prototyping, and manufacturing transition.
- Knowledge of IEC/ISO 60601, IEC 61010, medical device regulatory requirements, compliance activities, and regulatory submissions.
Nice to have
- Experience with third-party laboratory testing, simulation analysis, and IEC safety and EMC certification.
- Knowledge of motor systems, motion control, rotating machinery, pneumatic systems, fluid-handling mechanisms, and thermal dynamics.
- Familiarity with cables, shielding, system-level electromechanical integration, and continuous improvement initiatives.
Culture & Benefits
- Diverse and dynamic work environment within a research and development organization.
- 401(k) with up to a 6% employer match and no vesting period.
- Employee stock purchase plan and potential long-term incentive plan participation.
- Flexible time off for salaried employees, paid sick time, paid and floating holidays, and parental leave.
- Short- and long-term disability insurance, tuition reimbursement, and health and welfare benefits.
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