Join Team Vave
We are on a mission to change the paradigm of healthcare, starting with ultrasound.
Vave Health is a healthcare technology startup based in the Bay Area. Our next-generation wireless ultrasound solution enables faster diagnosis and treatment at the point of care resulting in better patient outcomes. We believe that by working passionately in concert with clinicians and other creators, we will bring the most efficient and effective products to the medical field. Vave is accelerating access to imaging by designing the first wireless ultrasound-as-a-service platform. The low-cost subscription includes a portable ultrasound device, intuitive software, and Vave Health’s customizable educational platform. Our mission is to increase access to innovative imaging, improving the quality of care for those who need it most.
At Vave Health, we are committed to equal employment opportunities. Vave company offers a drug-free work environment to all qualified applicants without regard to race, religion, color, sex, age, national origin, sexual orientation, disability, marital status, veteran status, or any other category protected by applicable law. Equal employment opportunity includes hiring, training, promotion, transfer, demotions, and termination.
Lead Mechanical Engineer
Purpose & Description
The Lead Mechanical Engineer will own the design, development, and delivery of all Vave’s mechanical components and subsystems. The Lead Mechanical Engineer is responsible for the high-level and detailed design of Vave mechanical components. A natural problem solver, able to contribute to all aspects of development, testing, and document generation. The Lead is also responsible for troubleshooting and failure analysis, as needed.
As Lead Mechanical Engineer, this individual will work with cross-functional teams to build and deliver new products. Responsible for material selection and equipment sizing in compliance with codes and standards. You will work closely with project teams to determine work scope requirements, monitor, and control project costs, and pro-actively resolve variances from project plans. This role is ideal for someone who has a technical background and enjoys being “hands on”.
Specific Duties & Responsibilities
- Work with hardware and cross-functional teams to identify, understand, and define design specifications and develop mechanical components to meet them
- Generate novel and unique solutions to technical challenges in mechanical designs, including injection molding, die-casting/thixo-molding, or compression molded parts. Develop innovative solutions to waterproofing, latching, locking, or usability challenges
- Develop plans, protocols, reports, bench tests, and fixtures to verify mechanical designs
- Use prototyping solutions to quickly develop proofs of concept of the designs
- Perform formal release of documentation in support of quality and regulatory requirements for medical devices
- Analyze and debug failures found during system testing and use
- Work with domestic and international vendors and CMs
- Develop test and assembly fixtures, and work instructions for manufacturing
- Identify opportunities for scalable processes for mass production to reduce COGs and overhead
- Work with the manufacturing team and CM on NPI and mass production.
- Maintain knowledge of current technical advancements in the general field of mechanical engineering, rapid prototyping, volume manufacturing by keeping up with current developments and trends
- Contribute to teamwork in an Agile development environment
- Support and conduct validation studies, technology transfer activities, process characterization studies, and gauge R&R studies within the manufacturing process. Provide guidance on the equipment/process validation requirements and design control activities for new product development projects
- Lead cross-functional group in conducting analysis of NCMRs, with the purpose of evaluating the underlying issues and offering long-term solutions. This includes the completion of required CAPA processes. Document and implement system improvements
- Responsible for ongoing process improvement: take initiative to define, plan, and execute improvement projects, achieve objectives in increasing yields, reducing cycle time, reducing overall cost, and improving product quality and reliability
- Maintain and improve existing product manufacturing processes. Anticipate manufacturing’s need for new products and fixtures
- Survey and identify replacement components for reasons of obsolescence or cost reduction.
- Work with the quality team to drive component issues upstream to suppliers. Use continuous improvement process in yield and quality/reliability programs
- Review product designs for compliance with engineering principles, company quality and regulatory standards, customer requirements, and related specifications
- Troubleshoot or refine existing products and raw materials components. Provide instruction and support to manufacturing and QA on manufacturing techniques, procedures, and QC inspections
- Conduct failure mode investigations (FMEA), and risk analysis of medical devices according to FDA QSR
- Coordinate with external test labs to conduct compliance and environmental testing
- BS, MS, in Mechanical Engineering or related fields
- Minimum 6 years of experience developing mechanical systems, and minimum 3 years developing medical devices. Experience developing devices according to FDA and IEC 60601-1 standards desirable.
- Experience with plastic parts for volume production
- Experience with relevant fabrication techniques such as injection molding, ultrasonic welding, laser welding, machining, casting, and 3D printing
- Experience developing lab test software (e.g. LabView or similar, Python scripting)
Knowledge & Training
- Expert knowledge in designing for volume molding processes (injection, die-casting, compression, over-molding, etc.)
- Experience with polymers and metals, and their properties
- Proficiency with SolidWorks and associated PDM tools
- A record of owning projects successfully and working in a fast-paced environment
- Thorough understanding of DFM
- Self-driven personality, startup mindset
- Working knowledge of CAD design and simulation tools (SolidWorks preferred).
- Experience with engineering change orders, documentation needs, protocol, and report writing. Familiarity with FMEA, DOE, and QSR design control
- Hands-on prototyping and testing abilities
- Knowledge of supplier quality systems processes
- Results-oriented self-starter. Ability to prioritize tasks and work independently
- Ability to assess the feasibility of design modifications to existing designs
- Experienced in troubleshooting and recommending corrective or preventive actions to improve product reliability
- Experience with medical product manufacturing including new product introduction, product transfer and scale-up
- Experience in implementing and using automated systems engineering tools
- Experience with human factors assessment
- Process development or technology transfer experience (proven track record of new product and sustaining support with contract manufacturers)