Senior R&D Engineer (Electrical / Sustaining Engineering)
60 Days Old
Essential Duties and Responsibilities
- Develop project plans, timelines, milestones for product design changes originating from Operations.
- Perform verification and validation of design changes. Perform risk management in accordance with ISO 14971.
- Document design changes and design transfer within the design history file and execute product development according to pertinent regulatory requirements (e.g., QSR, ISO 14385).
- As needed, serve as the primary investigator of device failures or unexpected behaviors observed on returned product.
- Serve as the planner and subject matter expert for new product introduction, manufacturing transfer, and sustaining product(s) through product lifecycle(s).
- Collaborate closely with production, supply chain, and manufacturing functions to establish priorities for increased quality, throughput, and scalability.
- Develop clinical rationales for specification revisions required for any transferred products.
- Collaborate with Quality and Operations teams to close NCR and CAPA investigations related to transferred products.
Other Duties and Responsibilities
- Other duties as assigned.
Education and Required Experience
- Bachelor's degree in electrical, software engineering or equivalent combination of relevant coursework and job-related experience.
- Experience with managing multiple time-sensitive projects simultaneously and managing project priorities (important/urgent).
- 5 - 8+ years of experience in FDA regulated medical product development environments
Knowledge, Skills, and Abilities
- Strong foundation in education, skills in electrical and software engineering and tools for a thorough technical analysis of product failures.
- Expert in tools and processes for root cause analysis.
- Application of statistical methods in manufacturing and product development
- Understand medical implantable, equipment, and disposable standards and manage standards testing. Requires managing external suppliers to perform a variety of standards testing.
- Create project list dashboards that shares status to all stakeholders.
- Proven knowledge of development, manufacturing, and quality system requirements for medical devices.
- Strong interpersonal, communication (verbal and written), organizational and project management, time management skills.
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.
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 https://www.ebrsystemsinc.com/ 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!
- Location:
- Sunnyvale
