San Francisco Bay Area, CA
Sr. Principal R&D Engineer – Mitral Valve
- Structural heart and/or steerable catheter experience. (most preferably in Mitral repair)
- Strong track record of creative design
- Self-motivated and can identify design requirements and implement
- Extensive experience in a clinical setting
- Experience in echocardiography guide procedures
- Strong Solid works skills
Research and develops products, materials, processes, or equipment for complex projects. Compiles, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials. As a key member of the research and development team, the employee will independently perform complex and diverse functions to support Research and Development.
Responsibilities and functions:
- Fully leads, participates, and successfully contributes to project teams typically including the following activities: equipment and product design and development, test of materials, preparation of specifications, process capability studies, research investigations (animal and clinical studies), report preparation, and process/test documentation.
- Works independently to plan and schedule own activities necessary to meet timelines.
- Designs/develops and coordinates standard engineering tests and experiments to include validation planning and execution.
- Designs/develops, procures, and fabricates tooling and fixtures.
- Performs troubleshooting on new products/process problems as related to design, material, or process.
- Summarizes, analyzes, and draws conclusions from test results.
- Prepares reports, documentation, and presentations to communicate results to Executive Leadership, Board of Directors, and technical community.
- Responsible for preparing and reviewing engineering documentation.
- Invents/ creates concepts and designs for new products/processes, and submits idea disclosures.
- Hire, train, and provide work direction to engineers and technicians.
- Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing to develop project plans and strategy and ensure project success.
- Works with internal and external customers to acquire product needs and translate into project/product plan
- Develop resourcing needs and timelines for project execution
- Locate, review, and manage external vendors and suppliers to ensure project/product needs are completed
- Work with internal and external experts along with hired counsel to construct, maintain, and protect useful and valuable intellectual property
- Develops and Demonstrates PDP/TPD system knowledge through delivery of high quality deliverables.
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements
- Product Development support;
- Creation / editing of VPI’s, HR’s, DCR’s, etc., as needed
- Assisting with validations and QC functions
- 10 years’ experience with a Bachelors’ Degree in Engineering, Technical or Related Field Experience with manufacturing and R & D
- 7 years’ experience with Cardiovascular catheter/implant design and development
- Excellent attention to details, multi-tasking ability, highly organized
- Efficient, reliable, hands-on and must be able to work independently with minimal supervision
- Professional acumen – good communications skills
Essential Mental/Physical Functions:
- Travel occasionally. (20 % of time)
- Able to lift up to 30 lbs.
- Use a computer keyboard up to 50% of the day.
- Work in a sitting position for extended periods.
- May be subject to those hazards associated with the office environment machine shop and production tooling (moving parts, electrical current, high heat, and flammable chemicals).
- 8 years’ experience with a Masters’ Degree in Engineering, Technical or Related Field Experience with manufacturing and R & D.
- 5 years’ experience with structural heart catheter/implant design and development