Mechanical Engineer

Mechanical/Product Development Engineer: Our CEO has successfully led five acquisitions throughout her career and in July 2021 raised Series A financing of $10 million with marquee investor Wavemaker 360 Health and FemTech-focused investors Women’s Venture Capital Fund, Golden Seeds, and Astia Angels.

We are developing two products to improve women’s health: (1) is designed for first-time mothers, who will have vaginal births, to mitigate unnecessary injury to their pelvic floor muscles and (2) is a non-surgical vaginal dilator to relax the pelvic floor muscles and achieve vaginal elasticity for women who suffer from pelvic floor injuries.

We are partnering with our CEO to hire our Lead Mechanical Engineer, which will be proficient in SolidWorks and responsible for: New product development (creating an R&D pipeline) Re-design of both of our products Testing, V&V, vendor management, etc.

The Role: Seeking a hands-on Product Development Engineer experience with medical device design & development.

The candidate must be comfortable working in a regulated quality management system and have previous exposure to the development process.

A broad set of skills and capabilities will be required to support a growing start-up and the development of electromechanical devices.

The ideal candidate will have a strong willingness to be hands-on and support a wide variety of activities as dictated by the ever-changing startup environment.

Responsibilities: Define and test solutions to problems found during testing Support in house manufacturing of prototype designs for clinical use Troubleshoot field issues and customer feedback of the existing devices Fabricate prototypes, perform engineering analyses and risk assessments Create drawings, reports, and other documentation to support development activities Participate and contribute to system-level project discussions, planning, and design reviews Concept development of next-gen products including design improvements and COGS reduction Works collaboratively with Regulatory, Quality, and Operations at all stages of development, as needed Complete design revisions of the existing devices in support of regulatory submission and commercial launch Perform a wide range of verification/validation activities, including specification and test method development Design and perform experiments and document results to determine potential design feasibility and characterization Design, fabricate and/or specify test fixturing and equipment used for device feasibility, development, characterization, and verification What is Needed for Success : FDA medical device experience Ability to commute to Mountain View Design for injection molding preferred Exceptional technical problem-solving skills High level of proficiency in SolidWorks and CAD Ability to commute to Mountain View 4 or 5 days per week Experience with medical device conceptualization and design Medical device electromechanical systems experience required Experience with VNV, IEC-60601, and additional compliance standards Cross-functional integration experience with electrical engineering, software, etc.

Willingness to be hands-on and wear many hats to support the engineering team Track record of adherence and compliance to FDA and other regulatory standards