Lead Mechanical Engineer

SleepRes, Inc.•Fremont, CA
•$190,000 - $215,000

About The Position

SleepRes is seeking a Lead Mechanical / Pneumatic Engineer to lead mechanical, pneumatic, thermal, and acoustic development for current and next-generation positive airway pressure (PAP) therapy systems. This hands-on technical leadership role owns the device mechanical and air-delivery architecture, including blower integration, airpath, enclosure, humidification, breathing-circuit interfaces, thermal performance, and acoustics, from concept through commercialization. The engineer works closely with systems, electrical, firmware, V&V, NPI, quality, regulatory, overseas suppliers, and contract manufacturers to translate product requirements into reliable, manufacturable designs. The role may be filled at the Staff or Principal level based on experience, technical scope, and demonstrated leadership. Staff-level engineers typically have 8+ years of relevant product-development experience and serve as the primary technical owner for the mechanical/pneumatic discipline. Principal-level engineers typically have 10–12+ years of relevant experience and demonstrated platform-level technical leadership, establishing engineering standards and influencing multiple product generations.

Requirements

  • Bachelor's degree in Mechanical Engineering or a related engineering discipline; a master's degree is preferred.
  • At least 8 years of relevant mechanical product-development experience; Principal-level candidates typically have 10–12+ years and demonstrated platform-level technical leadership.
  • Strong knowledge of fluid mechanics, pressure/flow systems, thermal engineering, mechanical design, tolerance analysis, injection-molded plastics, seals, and DFM/DFA.
  • Strong CAD capability using SolidWorks, Creo, or a similar professional mechanical-design platform.
  • Demonstrated experience taking complex electromechanical products from concept through commercial production.
  • Hands-on experience with prototyping, engineering characterization, laboratory testing, and multidisciplinary root-cause investigation.
  • Experience working directly with contract manufacturers and component suppliers.
  • Strong systems thinking and communication skills, with the ability to lead technical decisions in a fast-paced, cross-functional environment.

Nice To Haves

  • Experience developing CPAP, ventilator, respiratory, anesthesia, oxygen-delivery, or other pneumatic medical devices.
  • Medical-device development experience under ISO 13485 and FDA design controls/QMSR.
  • Familiarity with applicable IEC 60601, ISO 80601, and ISO 18562 requirements.
  • Experience with acoustic engineering, vibration analysis, CFD, FEA, or accelerated reliability testing.
  • Experience with high-volume Asian manufacturing partners and suppliers.
  • Experience leading mechanical engineers or serving as the mechanical technical lead for a multidisciplinary product program.

Responsibilities

  • Lead mechanical and pneumatic architecture, design, development, and verification for SleepRes PAP products.
  • Own blower integration, airpath, pressure/flow paths, humidifier and water chamber, enclosure, seals, breathing-circuit interfaces, thermal management, and acoustic/vibration performance.
  • Translate system requirements into mechanical and pneumatic specifications, interfaces, and design solutions.
  • Perform and review first-principles analysis, including airflow, pressure drop, thermal performance, tolerance stack-up, structural performance, and acoustics.
  • Drive rapid prototyping and product development through EVT, DVT, design freeze, formal V&V, PVT, and commercial production.
  • Lead mechanical design reviews and work with NPI, suppliers, and contract manufacturers on DFM/DFA, tooling, fixtures, assembly processes, and design transfer.
  • Support verification, reliability testing, and root-cause investigations for mechanical, pneumatic, thermal, acoustic, and manufacturing issues.
  • Partner with Operations and Strategic Sourcing on supplier selection, alternate-source qualification, value engineering, and cost reduction.
  • Support design controls and risk management, including requirements, specifications, DFMEA, verification documentation, engineering reports, and design changes.
  • Mentor engineers and help elevate the team's mechanical engineering capability.
  • At the Principal level, establish engineering standards, resolve complex multidisciplinary problems, mentor senior engineers, and influence multiple product generations.
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