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