Senior R&D Engineer - Mechanical Engineering

The Senior R&D Engineer will develop 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

• 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.
• 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 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.
• 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.
• 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. 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.

Disclaimer: EBR Systems Inc. will never ask for personal identifying information (such as Social Security Number, bank account details, or credit card information) during the application process. All communication from EBR Systems Inc. regarding job opportunities will be conducted through official company channels.

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.

The final starting salary offer to the successful candidate will be determined by evaluating several factors, but not limited to experience, knowledge, skills, internal equity, and alignment with market data.

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

Company Overview

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 ground-breaking technology to market.

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

• Medical, dental, and vision insurance
• 401K Matching Plan
• PTO - starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• 401(k) Bonus Program
• Life and AD&D Insurance
• Weekly company lunches and occasional happy hour events
• Meaningful work!