Senior Mechanical Engineer
Company: EBR Systems Inc
Location: Sunnyvale
Posted on: January 27, 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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