Senior Mechanical Engineer

20 hours ago

San Carlos, California, United States Noah Medical Full time
About Noah Medical

Noah Medical is a pioneering company in the field of medical robotics, dedicated to revolutionizing the future of healthcare. Our cutting-edge robotic platform is designed to facilitate early diagnosis and treatment of patients across multiple indications.

Job Description

We are seeking an exceptional Managing Principal Mechanical Engineer to lead a small technical team in developing complex medical disposables, including instruments and accessories used for robotic surgery. This individual will serve as the primary interface between various cross-functional teams, including Clinical, Marketing, Systems, Robotic Controls, Electrical Engineering, Software, Manufacturing, and Operations.

Key Responsibilities
  • Provide technical leadership for the design and development of complex robotic medical devices, primarily including instruments and accessories.
  • Lead a small (2-4 person) technical team, providing guidance, mentorship, and managerial support.
  • Maintain a level of individual contribution alongside overall technical leadership.
  • Create problem statements, concepts, and have strong engineering expertise to guide projects to a manufacturable, robust design for production.
  • Develop and maintain detailed product development project plans with associated schedules and successfully execute against them.
  • Interface with various cross-functional teams to fully define product requirements and implement creative solutions in a fast-paced environment.
  • Lead the close collaboration with NPI and manufacturing teams for seamless transfer of product to manufacturing.
  • Develop and document the finished product design documentation package, including component and assembly drawings, product requirements, specifications, test methods, protocols, and reports in support of V&V activities.
  • Design and develop initial assembly processes, including assembly/testing tools/fixtures to aid in assembly and conduct in-process manufacturing quality assurance.
  • Participate and lead design reviews, dFMEA, and other design de-risking and documentation activities.
  • Lead continuous improvement programs to improve the performance of robotic instruments and accessories and/or reduce the cost and complexity of the same.
  • Manage and mentor less experienced engineers on the technical team and cross-functionally to reach their full potential.
Requirements
  • Demonstrated success in design and development of complex medical devices, preferably with experience in robotically controlled instruments and associated accessories.
  • Deep knowledge in medical device product development, including single-use disposables, robotic applications in the medical space, and/or endoluminal medical device development.
  • Experience with medical device sterilization processes, validations, and packaging.
  • Demonstrated ability to successfully design and develop complex mechanical products and manage, coach, and develop a small team of engineers concurrently.
  • Ability to prioritize between critical project activities, making appropriate trade-offs to successfully meet challenging project milestones.
  • Experience successfully commercially launching new products and smoothly transferring same to production while hitting COGS targets.
  • Hands-on experience with risk analysis, risk mitigation, and dFMEA.
  • Demonstrated success working with multi-disciplinary, cross-functional teams.
  • Advanced SolidWorks user with experience using SolidWorks CAD and SolidWorks PDM tools.
  • Knowledge of regulatory standards, such as IEC and FDA 510(k) submission process.
  • Familiarity with agile management tools, such as Jira, Jama, Arena, or similar.
  • Excellent communications skills and the ability to explain complex problems in plain language to cross-functional teams.
  • Must have prior experience working in a fast-paced startup (or similar) environment.
  • B.S. degree in Mechanical, Bio-medical, or related discipline. M.S. degree or PhD preferred.

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