Leads mechanical architecture, design, simulation, verification, validation, and risk management for complex medical devices from conception through launch. Performs tolerance analysis, FEA, kinematic modeling, prototyping, and design-for-manufacturing optimization. Ensures compliance with medical device quality systems and regulations while collaborating with manufacturing, quality, and supply chain teams. Mentors junior engineers, manages multiple projects, and prepares technical documentation and presentations.
The Senior Mechanical Engineer will play a crucial role in the research and development team, focusing on the design, development, and optimization of complex medical devices, materials, and combination products from conception through launch.
Job requirements
Education & Qualifications:
Job responsibilities
Benefits
Benefits:
Disclaimer:
The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Job requirements
Education & Qualifications:
- BS in Mechanical engineering (Masters Preferred)
- 8+ years of dedicated mechanical design experience, with at least 5 years specifically in the medical device industry
- Expert-level proficiency in CAD/solid modeling (Solidworks or equivalent)
- Strong knowledge of materials & fabrication/manufacturing/injection molding technologies
- Experience with FEA, CFD or other engineering simulation tools
- Deep mastery of medical device design controls and regulations (e.g. ISO 13485, ISO 14971, ISO 60601)
- Ability to work independently, analyse data rigorously, and manage multiple priorities.
- Excellent written and verbal communication skills.
Job responsibilities
- Lead the mechanical architecture and detailed design of complex, multi-component patient connected medical devices using CAD and simulation tools.
- Translate user needs into functional requirements and prototypes using advanced manufacturing techniques.
- Perform rigorous tolerance analysis (GD&T), structural/thermal FEA, and kinematic modeling to ensure absolute reliability in clinical environments.
- Architect and execute comprehensive Verification and Validation protocols within ISO 13485 and FDA 21 CFR Part 820 quality systems.
- Collaborate directly with manufacturing, quality, and supply chain teams to optimize designed for manufacturability (DFM), assembly (DFA), and cost at scale.
- Drive technical risk management (compliance with ISO 14971) through hazard analysis, fault tree analysis, FMEA, and rigorous root cause investigations.
- Provide technical guidance and mentorship to junior engineers and other design staff
- Manage multiple projects balancing technical priorities, timelines & budgets.
- Prepare technical documentation, reports and presentations for internal & external stakeholders.
Benefits
Benefits:
- Competitive salary and benefits package
- Opportunities for professional development and career growth.
- Collaborative and innovative work environment.
Disclaimer:
The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Similar Jobs
Professional Services • Consulting
Leads mechanical engineering design and construction projects, ensuring technical quality, code compliance, QA/QC, timely delivery, and client satisfaction. Delegates work, coordinates multidisciplinary teams, reviews submittals, performs site investigations and life-safety analysis, and manages department workloads. Mentors engineers and designers, supervises staff, supports business development, maintains project documentation, and develops company standards. Requires proficiency in Revit, AutoCAD, Carrier HAP, Trane TRACE, and eQuest, plus a PE license and active NCEES registration.
Top Skills:
3D Imaging CamerasAutocadCarrier HapEquestExcelMicrosoft OutlookMicrosoft WordNceesNewforma KonektRevitTeamganttTrane Trace
Professional Services • Consulting • Design
Leads the design and execution of complex mechanical, HVAC, plumbing, and specialty systems for institutional and healthcare facilities. Oversees design quality, construction documents, specifications, construction administration, project timelines, and coordination with multidisciplinary teams. Drives LEED certification, energy modeling, lifecycle cost analysis, and sustainable design compliance with federal regulations and applicable codes. Requires a mechanical engineering degree, professional engineering license, extensive MEP design experience, LEED certification, and proficiency with Revit, HAP, TRACE 3D Plus, and Bluebeam.
Top Skills:
Ashrae 62.1Ashrae 90.1BluebeamBoiler PlantsChiller PlantsExcelGreen GlobesHapHvacHydronic SystemsIfgcImcIpcLeedMedical Gas DistributionMicrosoft 365Microsoft TeamsNfpa 99OutlookPlumbing SystemsRevitSharepointSpeclinkSpecsintactTrace 3D PlusVavVrfWater Source Heat PumpsWord
Energy • Utilities
Leads end-to-end design and deployment of balance-of-plant systems for a first-of-a-kind nuclear power plant. Responsibilities include thermal, fluid, structural, and mechanical analysis; system architecture; equipment specifications; vendor engagement; procurement; regulatory documentation; CAD; design reviews; manufacturing and integration planning; testing; commissioning; and plant bring-up. The role owns steam, feedwater, condensate, condenser, heat exchanger, and turbine-side systems while coordinating cross-functional interfaces and managing contractors.
Top Skills:
AbaqusAir-Cooled Condenser SystemsAnsysAPIsAsmeCadCfdCreoFeaFemapGd&TNfpaNrcNxPiping SystemsPressure VesselsRankine CycleSolidworksSteam Turbine Systems
What you need to know about the Austin Tech Scene
Austin has a diverse and thriving tech ecosystem thanks to home-grown companies like Dell and major campuses for IBM, AMD and Apple. The state’s flagship university, the University of Texas at Austin, is known for its engineering school, and the city is known for its annual South by Southwest tech and media conference. Austin’s tech scene spans many verticals, but it’s particularly known for hardware, including semiconductors, as well as AI, biotechnology and cloud computing. And its food and music scene, low taxes and favorable climate has made the city a destination for tech workers from across the country.
Key Facts About Austin Tech
- Number of Tech Workers: 180,500; 13.7% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Dell, IBM, AMD, Apple, Alphabet
- Key Industries: Artificial intelligence, hardware, cloud computing, software, healthtech
- Funding Landscape: $4.5 billion in VC funding in 2024 (Pitchbook)
- Notable Investors: Live Oak Ventures, Austin Ventures, Hinge Capital, Gigafund, KdT Ventures, Next Coast Ventures, Silverton Partners
- Research Centers and Universities: University of Texas, Southwestern University, Texas State University, Center for Complex Quantum Systems, Oden Institute for Computational Engineering and Sciences, Texas Advanced Computing Center
