Senior Principal R&D Engineer, Product Design

at Edwards Lifesciences Gruppe
Location Irvine, California
Date Posted July 30, 2022
Category Engineering
Job Type Not Specified

Description

The Senior Principal Engineer will work within a cross functional team on the development of devices (implant and/or accessories), and therapies for open-heart surgeries from concept to launch. This engineer will serve in a technical role and collaborate closely with key internal and external stakeholders to ensure the design meets user needs, including but not limited to clinical effectiveness, device ease of use, and manufacturability. In addition to technical responsibilities, this engineer will exercise leadership and knowledge of Design Control and New Product Development processes to deliver on project milestones. Key Responsibilities: Apply sound engineering principles and practices to the design and testing of medical devices Generate engineering models, drawings, prototypes and work instructions. Evaluate and make recommendations on concepts and design modifications based on key stakeholder feedback Establish/characterize product and/or process specifications Interface with operations and supply chain stakeholders to design for manufacturability and cost effectiveness Work with and provide oversight to suppliers on the design and procurement of components, tooling and fixtures for the design, testing, inspection or assembly of products Support efforts to generate, review, and approve design control documentation Develop test plans, protocols, and reports. Analyze and present results, applying statistical analysis as necessary Collaborate with physicians and other key stakeholders to define user needs and design requirements Support technical update meetings, design control review meetings, completion of required project deliverables, and execute follow up activities with cross functional team members on action items Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity on designing parts, components and subsystems Train, coach, and guide lower level employees on more complex procedures Other incidental duties Basic Qualifications: B.S. degree in Mechanical Engineering, Biomedical Engineering, or related discipline and 8+ years' experience is required -OR- Master's degree in Mechanical Engineering, Biomedical Engineering or related field and 7+ years' experience is required Proficiency with Pro/E Creo -and/or- Solidworks is required Preferred Qualifications: Experience designing with a variety of plastic and alloy materials Experience with surgical devices, cardiovascular devices, implantable material experience or other medical devices Knowledge of Design Control requirements and experience generating documentation including Design Requirements, Risk Management, Design Verification and Validation Technical leadership capability with strong self-motivation, results orientation and organization skills Possesses a successful track record of product development from concept through launch in medical devices or other highly regulated field Ability to work on complex problems and projects independently with minimal supervision where analysis of situation or data requires an in-depth, solid understanding of engineering principles. Use creative ability to design and problem solve Effective verbal/written communication and interpersonal skills including conflict and relationship management Experience in one or more of the following: surgical heart valve replacement and/or repair devices and therapies, multi-lumen catheters, minimally invasive surgical devices, fluoroscopy-guided and/or echo-guided MIS therapies Black belt certification Experience with Geometric Dimensioning & Tolerancing per ASME Y14.5M Additional Skills: Excellent documentation and communication skills Excellent interpersonal relationship skills including negotiating and relationship management skills Advanced problem-solving, organizational, analytical and critical thinking skills Strong leadership skills and demonstrated ability to influence change Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Represents organization as key technical contact on contracts and projects Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.

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