Sr. R&D Engineer, Heart Valves
Company: TriFlo Cardiovascular Inc.
Location: Newport Beach
Posted on: February 19, 2021
This may be the job opportunity for you if you are intrigued by
the idea of working with a multi-disciplinary team pioneering
cutting-edge technology in the biomedical space.
We are a well-funded start-up, led by a team of passionate leaders
moving swiftly toward our goal of fulfilling a greatly unmet
clinical need in heart valves therapies. We are looking to hire a
highly skilled and motivated Senior R&D Engineer to play a
critical role in the growth of our company.
The Senior Engineer will be a key contributor to the design and
development of our novel transcatheter technology. A strong
candidate will be a hands-on leader with sound technical knowledge,
strong multi-tasking skills, and the ability to work in synergy
with a highly driven and dynamic technical team focused on reaching
clinical trials next year. Prototyping skills are highly desired.
This position will report directly to the Chief Operating Officer.
Essential Responsibilities Include
- Apply comprehensive & diverse knowledge of engineering
principles to a broad range of assignments.
- Plan, conduct & direct engineering assignments to
- Design, prototype and evaluate complex interventional catheters
for delivery of implantable devices.
- Contribute to decision-making in all areas of project including
financial, marketing, planning, quality & design.
- Provide scientific support by interpreting safety and
effectiveness results data, including data mining, compiling,
analyzing and summarizing data from all applicable sources.
- Complete assignments involving a specific phase of an
engineering project which may include design, development,
- Manage and drive timelines for feasibility testing activities,
design verification testing, and clinical release testing.
- Co-ordinate, direct activities of other technical support staff
& be responsible for their assignments.
- Co-ordinate activities with internal & external partners.
- Ensure product is properly designed for manufacture & suppliers
are properly selected & qualified.
- Develop, design, validate & start up manufacturing & assembly
operations that meet team objectives for product quality, cost &
- Conduct qualification of manufacturing related equipment,
tools, gages, fixtures, processes, as required.
- Input manufacturing requirements into product design to ensure
design for manufacturability & team goals are met.
- Actively participate in Quality Function Deployment, market
research, design FMEA, Business Plan development & other team
activities to help ensure total team success.
- Using appropriate statistical techniques, develop validation
protocols, qualify first articles, complete process capability
studies & process validation on both internal & supplier
- Other responsibilities may be assigned as required.
- Ensure documents comply with regulatory guidelines.
- Up to 15% travel to conferences/physician meetings.
QualificationsRequired skills and experience must include, but may
not be limited to:
- Comfort with all phases of product development lifecycle
including concept generation, design, rapid prototyping,
manufacturing, verification & validation and qualification
- Must be able to work in a multi-functional team
- Ability to provide feedback in a professional, direct, and
- Proven hands-on prototyping skills of complex cardiovascular
implants and delivery systems.
- Good written and verbal communication, interpersonal, and
relationship building skills.
- Problem solving methodology, root cause analysis, and GDP (Good
- Skills in mechanical design and Delivery System catheter
- Bachelor's degree in Engineering (mechanical or biomedical
preferred) - an advanced degree will offset some required
- 5+ years of professional experience - including medical device
product development, writing test protocols, and writing
- 5+ years of SolidWorks experience for prototyping.
- 5+ years of experience with catheter development.
- Proven ability to apply technical knowledge and judgment to
complex engineering problems.
- Knowledge of and adherence to Environmental Health and Safety
and Quality guidelines as they relate to lab and/or clean room
medical device manufacturing.
- Adhere to all EHS rules and requirements and take adequate
control measures in preventing injuries to themselves and others as
well as to the protection of environment and prevention of
pollution under their span of influence/control.
Keywords: TriFlo Cardiovascular Inc., Newport Beach , Sr. R&D Engineer, Heart Valves, Engineering , Newport Beach, California
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