Senior Mechanical Engineer

Company: EBR Systems Inc
Location: Sunnyvale
Posted on: January 22, 2023

Job Description:

Description:
Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The company's patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management. We are a team of dedicated individuals, driven to deliver superior treatment of millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective and reliable therapies using wireless cardiac stimulation. As a fast-paced company, every team member at EBR makes a big contribution towards our mission. We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring a ground-breaking technology to market. The successful candidate is a hands-on Mechanical Engineer who will design and develop innovative medical devices in support of EBR's strategic plan. EBR Systems offers a great place to work as well as generous benefits and growth opportunities: Medical, dental, and vision insurance401KPTO - starting at 3 weeks per yearCompetitive salary with opportunities for career growthEmployee stock options401(k) Bonus ProgramLife and AD&D InsuranceWeekly company lunches and occasional happy hour events Duties & Responsibilities: Design and develop new products as well as product changes and enhancements which are consistent with a zero-defect level and low product cost. Solve complex problems at the product level and oversee development process through to the manufacturing stage.Generate effective testing protocols and reports. Design test methods and fixtures and execute testing. Analyze test results utilizing DOE and statistical methodology.Train and supervise assigned technicians and temporary workers. Oversee prototyping activities.Conduct complex design review meetings.Complete projects (including product changes and enhancements) in an aggressive manner consistent with corporate objectives. Independently determine day to day tasks consistent with corporate goals.Develop requirements and risk documents based on clinical and engineering inputs, applicable standards, and regulatory guidance documents (e.g., FDA). Establish and maintain traceability between requirements, risk documents, and testing.Contribute to the intellectual property position of the company via invention disclosures and patent applications. Maintain accurate documentation of concepts, designs, drawings, and processes.Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to EBR's products.Provide engineering and technical support of products introduced into both the domestic and international markets.Procure and oversee outside suppliers and consultants as required.Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post-production GMP compliance in coordination with the document control, clinical, and quality assurance functions. Provide support in the resolution of product complaints and/or safety issues.Work with manufacturing, clinical affairs, sales and marketing, and quality assurance functions to coordinate pilot production of new products.Support company goals and objectives, policies and procedures, good manufacturing practices, ISO, and FDA regulations.

Requirements:
Qualifications: Education & Experience:BSME degree or equivalent, MS preferred.With a BSME, 5 years of experience. With an MS, 3 years of experience.Product development experience in the medical device industry Experience with ISO 13485 and ISO 14971 preferred Qualifications:SolidWorks proficiencyStrong hands-on design and prototyping skillsStrong supplier management skillsStrong verbal and written communication skillsWorking knowledge of the patent processAbility to perform word processing and create basic spreadsheetsAbility to perform computerized project schedulingPI200804478

Keywords: EBR Systems Inc, Sunnyvale , Senior Mechanical Engineer, Engineering , Sunnyvale, California