Principal Mechanical Design Engineering Leader

Company: System One
Location: Brookline
Posted on: June 17, 2022

Job Description:

Principal Mechanical Design Engineering Leader Degree/Experience: - BSME /MSME with at least 15+ 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.) "MUST HAVES": - Subject Matter Expert (SME) in a wide range of engineering disciplines including: plastics, metals, materials, heat transfer/thermal management, electronics, sound and vibration measurement, damping techniques, rotating masses, basic & complex mechanisms, EMC mechanical mitigation, safety medical standards (IEC/ISO 60601 standard series, IVD 61010 standard series, etc.) compliance, design for reliability and planning, statistical sample size determination, hardware verification, systems engineering, tolerance analysis, finite element analysis, additive and subtractive design and manufacturing - Demonstrated success in 2D/3D (e.g. Solidworks) mechanical design, simulations, and reliability. Taking designs from concept to production - Demonstrated competence in methodical and effective troubleshooting. Excellent problem-solving skills (root cause analysis) - Demonstrated competence in mechanical product design & reliability tools and methodologies - Ability to document complex designs including: system requirements, theory of operation, 2D/3D drawings (e.g. Solidworks), test procedures, test reports, risk analysis, and failure analysis - Experienced leader in mentoring and assisting fellow colleagues in design and development - Design experience with FDA/IEC (IEC 60601-1 Safety standards) regulated medical devices is preferred Duties/Responsibilities: - Technical Leader and Subject Matter Expert (SME) in a wide range of engineering disciplines including: plastics, materials, heat transfer/thermal management, electronics, sound and vibration measurement, damping techniques, rotating masses, basic & complex mechanisms, EMC mechanical mitigation, safety medical standards (IEC/ISO 60601 standard series, IVD 61010 standard series, etc.) compliance, design for reliability and planning, statistical sample size determination, hardware verification, and systems engineering - 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 of size, weight, power, cost, environmental, and other use model conditions - Design, develop, and maintain medical device platforms that separates blood components (e.g. apheresis devices) for therapeutic treatments, blood transfusions, pharmaceutical industry, and diagnostic equipment to support the healthcare blood management industry - Lead technical discussions with key component suppliers in the areas of materials selection, critical to quality specifications, temperature/humidity/vibration specifications, optical sensors, electromechanical devices, motor mechanics, redundant mechanical safety systems, touchscreen user interfaces, fluid controls, and other technologies - Demonstrated technical success in translating Customer/User requirements/needs into reliable low-cost product designs - Build design tools and engineering capacities for modeling complex mechanical mechanisms with tight tolerances using various simulation tools, tolerance analysis, finite element analysis, and other software development environments - 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 DFX (design for manufacturing, design for reliability, design for serviceability.) - Lead existing product failure investigations: Investigate and determine root cause of product issues found in manufacturing and the field - Troubleshoot systems, mechanical parts, cables, connectors etc. Develop tools & test equipment to analyze and resolve issues - Demonstrating success in technical mentorship with peers and colleagues in reliable mechanical design - Lead and coordinate efforts to establish product reliability goals and to plan, execute and monitor activities aimed at achieving those goals post release Location: Boston, MA. (100% onsite role) Start Date: ASAP! Duration: Direct Hire

Keywords: System One, Brookline , Principal Mechanical Design Engineering Leader, Engineering , Brookline, Massachusetts