Senior Manager, Engineering -Transcatheter Heart Valve

  • Edwards Lifesciences
  • Irvine, CA, USA
  • Jul 20, 2020
Full time Health Care

Job Description

Edwards' Transcatheter Heart Valve business unit is looking for a Senior Manager to lead the New Product Development (NPD) team to pioneer next-generation delivery systems for transcatheter heart valve replacement platforms.

  • Will be responsible for: Leading an engineering NPD team that engages with other cross-functions early in the product development through design transfer; managing development activities for manufacturing processes of new products: Ensuring that the new products adheres to Design-for-Manufacturing principles: Establishing a strategy to build new devices and prepare for design transfer activities: Developing new manufacturing technologies to address anticipated factory needs for future applications

    Key Responsibilities:

    • Technical leader for development and integration of new manufacturing processes; main interface between R&D and manufacturing network
    • Plan and direct complex project activities (e.g., advanced engineering, core competencies) with large scale or significant business impact with the accountability for successful completion of all project deliverables to the business.
    • Develop project plans, schedule, scope, and quality objectives while using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design on new products and/or processes. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups and key stakeholders
    • Develop a robust talent development plan in alignment with functional growth strategies of the department
    • Development and execution of an Ops Strategy plan for assigned projects.  Build relationships with business partners to ensure the alignment of project objectives and activities.  Provide technical expertise and lead the facilitation of portions of the project strategy
    • Facilitate design/process reviews and apply DFM / LEAN principles to ensure key manufacturability considerations are incorporated early in the designs 
    • Survey emerging manufacturing technologies and explore novel applications to support company strategic goals
    • Promote knowledge sharing within the team and across teams/functions; actively develop engineering talent and acknowledge good work
    • Develop, communicate, and execute the strategy for the technical team to solve complex technical issues
    • Partner with commercial manufacturing sites to develop new process technologies
    • Manage and oversee the work of the NPD team with responsibilities of project milestones, risks and mitigations
    • Develop a robust talent development plan in alignment with functional growth strategies of the department including coaching, mentoring, and knowledge transfer         
    • Lead efforts to optimize business processes and systems by assessing business needs and developing, proposing and implementing technology solution options.

    Required Qualifications:

    • Bachelor's Degree in engineering or technical field
    • 10+ years of relevant work experience required
    • 3+ years of experience leading a technical cross-functional engineering team
    • 2+ years of experience with two or more of the following: catheter-based delivery systems, manufacturing automation systems, new product introduction, design transfer and process validations

    Preferred Qualifications:

    • An advanced degree or MBA is preferred
    • Expert knowledge of design controls for Class II & III medical devices; working with regulatory authorities
    • Proven track record in technology development and/or early-stage R&D; capable of articulating a strategy for progressing towards a loosely defined research goal
    • Strong business and financial acumen.  Ability to develop and manage project budgets, understanding of business case development including net present value and internal rate of return on capital investments.
    • Strong collaborator and communicator with a high degree of emotional intelligence and the ability to understand business partner needs and manage satisfaction relative to deliverables.
    • Ability to negotiate with and influence key stakeholders across the organization
    • Ability to see interdependencies within the company and comprehend how decisions affect other departments.
    • Demonstrated technical understanding of manufacturing engineering, design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN experience, cGMP and process validation
    • Ability to work in a fast paced, dynamic, and constantly changing work environment

    Every employee is essential to Edwards’ success, and we’re ready to help you advance along your career path!

    Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.