Mechanical Engineer Opening in Medical devices at Westface Medical
Mechanical Engineer – Medical devices
If you are a Mechanical Engineer with a disposables / durables medical device background, please read on! Based in Truckee, with R&D operations in Redwood City CA, we are a Medical Device startup developing opto-electro-mechanical devices for image-guided surgery. We are looking for a great ME to support medical device development from early R&D concepts through prototype and full development including pre-clinical testing, clinical evaluations, and regulatory approval.
Provides mechanical design, development and support leadership in a small cross-functional product development team developing a state-of-the-art image-guided surgical system. Works with company principals, other engineering disciplines and KOL physicians to design medical devices, resolve technical problems, ensure compliance to industry and regulatory standards. Devises new approaches to problems encountered. Works independently with minimal supervision but obtains guidance on unusual or complex problems and supervisory approval on proposed plans for projects. Maintains and supports a collegial work environment of continuous improvement in support of company Quality Policy, the Quality Management System and compliance to the appropriate regulations. Designs and develops products and enhancements which are consistent with goals of a zero-defect level and low product cost. Generate test protocols and conduct testing. Analyzes complex issues and presents to senior management with recommendations for action. Ability to evaluate and analyze procedural gaps Ability to react constructively in a high-energy and fast paced environment.
What You Will Be Doing – Using your experience and knowledge of user-conscious design, mechanical engineering, and medical devices to participate in the design and development of the company's products and intellectual property. Leads the development of the hardware design documentation for the projects. Participates in FMEA, risk assessment, requirements definition, detailed design, implementation, and verification and validation. Defines tasks associated with all phases of mechanical design and development, and provides accurate estimates of required effort and project completion dates. Develops and executes unit tests to verify functionality of work product. Provides ME expertise to the continuous improvement of product and processes. Accurately and thoroughly documents work in support of applicable ANSI/AAMI/IEC standards, ISO13485, FDA GMP and the requirements of all other relevant standards and all necessary documentation for planned regulatory filings.
Specific Initial Duties and Responsibilities:
1) Design and development of the disposable component of the SingleStick™ vascular access device. Work with Optical Engineers and Contract Manufacturers to prototype the insert, test with KOLs, work with senior management to select a CM and transfer the design to production, and work with Sales, Marketing and Field Service to address continuous product improvement, cost reduction, and end-user concerns and suggestions for new products.
2) Design and development of the clinical interface (HID, handpiece) between the SingleStick™ disposable and the imaging hardware. Work with Optical, Software and Electrical Engineers to prototype the handpieces and other HIDs, test with KOLs, iterate and refine the design, transfer to Production. Works with Sales, Marketing and Field Service on continuous improvement of the device and on suggestions for new products and HIDs.
3) Works with other engineering disciplines to ensure seamless integration and transfer to market of the SingleStick™ disposable, HID and capital equipment.
4) Build and maintain company CAD / CAM framework, document and design archival processes, and infrastructure compliant to medical device standards and industry best practices.
Education/ Experience: Bachelor’s Degree in Mechanical Engineering. 3+ years of technical experience in a regulated environment. High level of Solidworks proficiency including transfer to CMs and 3D printing facilities (local and remote). Versed in 21CFR Part 820, and should have been an active team member and participant in at least one medical device development cycle including use of document control software, verification and validation, and follow-up on field issues and improvements.
Proficient in written and verbal communication with attention to detail. Working knowledge of Microsoft Office Products. An ability to work independently and collegially with minimal supervision, establishing work priorities and direction.
Preferred: Active / lead participant in at least one full concept-to-market (medical) device development cycle preferably in a highly regulated environment. Project management skills including MS Project highly desirable, with the ability to align and balance potentially conflicting internal and external resources. 3D printer experience, light machine tools experience, working knowledge of the requirements of contract machine shops and job shops to ensure rapid turn-around on high-quality parts and assemblies. Broad knowledge of medical device and standard computer systems including selection of appropriate platforms and suppliers for hardware.
Principals only please
Applicants must be authorized to work in the U.S.
To apply click HERE.
Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Right to Work In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.