Senior Mechanical Engineer

1 day ago

Mountain View, California, United States Fresh Health, Inc. Full time
About the Role

We are seeking a highly skilled Senior Mechanical Engineer to join our team at Fresh Health, Inc. as we develop innovative medical devices to revolutionize oral health.

Key Responsibilities
  • Design, develop, and test medical devices in accordance with regulatory standards
  • Lead and design specific parts and systems, ensuring compliance with medical device regulations
  • Conduct Failure Mode and Effects Analysis (FMEA), develop test protocols, and create reports
  • Integrate ID and function into mechanical CAD, ensuring seamless integration
  • Develop work instructions and drawings, ensuring clarity and accuracy
  • Write and submit Engineering Change Orders, ensuring compliance with regulatory requirements
  • Collaborate with our contract manufacturer to identify areas of improvement and develop operations tools and processes
  • Work closely with Quality and Operations teams to evaluate supplier capabilities and build a robust supply chain
Requirements
  • Bachelor's Degree in Mechanical Engineering or equivalent engineering or scientific discipline
  • 7+ years of related work experience in medical device development
  • Experience in developing, testing, and launching medical devices
  • Experience with achieving functional safety certifications such as UL and IEC
  • Strong understanding of processes and materials used in medical devices
  • Strong understanding of the injection mold process, including DFM, fit check, FAI, and Cpk
  • Strong understanding of GD&T and tolerance stacking
  • Basic working knowledge of EE, RF, and electro-mechanical systems
  • Understanding of BOM/PLM management
  • Good verbal and written communication skills
  • Fluent in Solidworks
  • Experience in communicating and managing overseas suppliers
  • Experience in onsite troubleshooting during builds and developing solutions for short- and long-term issues
Preferred Qualifications
  • 10+ years of experience in medical device development
  • Experience working in a start-up environment
What We Offer
  • Competitive salary and equity
  • Health, dental, and vision benefits, including PPO, HMO/EPO, and HDHP
  • 90% employee + 50% dependent coverage
  • Retirement options: 401(k), IRA
  • Commuter benefits
  • Robust benefit options through our PEO, including Life/AD&D, disability insurance, global travel assistance, identity theft, HSA, FSA, medical & dependent care, employee assistance programs, physical, emotional, and financial wellbeing perks
  • Hybrid work model, generous vacation, and fun team events

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