Senior R&D Engineer (Mechanical Engineering)

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Description

The Senior R&D engineer will develop medical device products, requirements, risk documentation, test protocols, and test methods, execute testing, generate reports, and perform activities in support of EBR's strategic plan.

Essential duties and responsibilities include, but are not limited to, the following:

• Develop requirements based on clinical and engineering inputs, applicable standards, and regulatory guidance documents. Conduct risk assessments, provide solutions that mitigate identified risks, and generate risk documents. Establish and maintain design history file and traceability between requirements, risks, and design outputs.
• Lead the design verification and validation process. Develop test methods, design fixtures, generate test protocols, execute testing, and author test reports. Analyze test results utilizing DOE and statistical methodology.
• 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 problems at the product level and oversee the development process from concept through production.
• Collaborate with cross-functional teams and coordinate project activities to ensure products meet customer and market needs.
• Train and supervise assigned technicians and temporary workers. Oversee prototyping activities.
• Complete concurrent projects in an aggressive manner consistent with corporate objectives.
• Prepare and conduct design review meetings and presentations.
• Independently determine day to day tasks consistent with corporate goals.
• Contribute to the intellectual property position of the company via invention disclosures and patent applications. Maintain accurate documentation of concepts, designs, drawings, and processes.
• Stay current with competitive technologies and latest advancements in medical, technical, and biomedical developments related to EBR's products.
• Provide engineering and technical support for products introduced into both the domestic and international markets.
• Procure and oversee outside suppliers and consultants as required.
• Provide support in the resolution of non-conformances, 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. Ensure work complies with good manufacturing practices, standards, and regulations.

Other Duties and Responsibilities

• Support existing product line as needed.
• Perform other duties as assigned.

Education and Required Experience

• BS degree or equivalent in mechanical, electrical, biomedical, or related engineering discipline.
• Minimum of 5 years of experience within medical device manufacturing.

Knowledge, Skills, and Abilities

• Product development experience in the medical device industry, including product design, prototyping, design verification & validation testing.
• Knowledge of medical device regulations and standards preferred, including FDA, ISO 13485, and ISO 14971.
• Detail-oriented and strong problem-solving abilities.
• SolidWorks proficiency preferred.
• Strong project and supplier management skills.
• Strong verbal and written communication skills; ability to concisely explain technical concepts to technical and non-technical stakeholders.
• Proficiency with Microsoft Office and the ability to create analytical spreadsheets.
• Ability to perform computerized project scheduling.

Physical Requirements:

• Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms. Required to stoop, kneel, bend, crouch and lift up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.
• Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels.

EBR Systems, Inc. is an Equal Opportunity Employer committed to a diverse, inclusive, and equitable workplace.

Salary Range

$126,000 - $220,200*

• Base pay is one part of your total compensation. The salary offered will depend on several factors, including, but not limited to your experience, knowledge, skills, location, internal equity, and market alignment. Addition compensation may include bonuses and equity, along with a comprehensive benefits package.

EBR Systems, Inc. does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please refrain from solicitations at this time.

About the Company

What if your work doesn't just support innovation-what if it changes lives?

At EBR Systems, Inc., we are not imagining that future-we are building it. We are the team behind the world's first FDA approved, leadless left ventricular endocardial pacing device for heart failure. It's a breakthrough redefining what's possible in heart care, and it's just the beginning!

We don't just create game-changing medical devices-we grow people. Patients come first in everything we do. You will be empowered to solve real problems and to do meaningful work that truly makes a difference.

If you are driven by purpose, excited by challenge, and ready to shape the future of cardiac technology, we want to hear from you. Visit us at to learn more-and join us in our work Empowering Physicians, Powering Hearts.

EBR Systems offers a great place to work as well as generous benefits and growth opportunities:

• Medical, dental, and vision insurance provided at no cost for employee-only coverage
• 401(k) matching plan
• Paid Time Off - starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• Life & AD&D and long term disability insurance
• Education assistance
• Voluntary commuter benefits and pet insurance
• Weekly company lunches and occasional happy hour events
• Meaningful work and much more!