Senior Systems Engineer - Medical Devices - California, Sunnyvale

The announced job offer is made public by the firm: EBR Systems Inc and it was included in jobs list the date of: 2022-10-22 in the website greenenergyjobsonline.com.

It is announced that they have a job offer at the category of Engineering and the jobs location is in the state of California at the city Sunnyvale, in the country US - at this current ZipCode: 94085

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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 will lead and manage product development activities for new and existing products 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 insurance, life, AD&D, long-term disability
• 401K
• PTO - starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• 401(k) Bonus Program
• Life insurance
• Weekly company lunches and occasional happy hour events

Duties & Responsibilities:

• Lead and manage product development activities through to the manufacturing stage. Interface with multidisciplinary team and coordinate project activities.
• Design and develop new medical devices 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.
• 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. 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.
• Maintain a professional, credible image with key physicians, consultants, vendors, and co-workers.

Requirements:

Education & Experience:

• BS degree or equivalent in mechanical, biomedical, or related engineering discipline required, MS preferred
• Minimum of 7 years of relevant experience
• Experience in the medical device industry
• Product development experience for medical devices, specifically design control
• Experience with ISO 13485 and ISO 14971 preferred
• SolidWorks proficiency, preferred familiarity with Altium
• Strong project and supplier management skills
• Strong verbal and written communication skills
• Familiarity with project management tools

PI