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Sr. R&D Engineer, Heart Valves

Company: TriFlo Cardiovascular Inc.
Location: Newport Beach
Posted on: February 19, 2021

Job Description:

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 completion.
  • 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, testing.
  • 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 & performance.
  • 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 processes.
  • 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 environment.
    • Ability to provide feedback in a professional, direct, and tactful manner.
    • 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 Documentation Practices).
    • Skills in mechanical design and Delivery System catheter design.
    • Bachelor's degree in Engineering (mechanical or biomedical preferred) - an advanced degree will offset some required experience.
    • 5+ years of professional experience - including medical device product development, writing test protocols, and writing reports.
    • 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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