Exceptional opportunity to join a highly talented Transcatheter Mitral Tricuspid Therapies (TMTT) New Product Development (NPD) Team working on early stage design process. Responsible for leading Op’s Integration activities phases of design and process development and clinical (First in Man) FIM launch of delivery systems of Class III devices to treat cardiovascular disease. Serve as a core team member on new product development teams ensuring culture alignment across functions.
Essential Job Functions
- Responsible for the overall development and deployment of NPD teams. Drive execution of identified opportunities. Drive the development and manage the execution of NPD activities. Assess, analyze results, make recommendations, and develop strategies and reports and collaborate with team members to drive Op’s integration culture and discipline.
- Utilize engineering methods (e.g. SIX Sigma, LEAN, etc.) to identify technical Gaps to establish Product and Process Capabilities, while employing technical design skills to re-design/design new products and/or processes. Ensure new products and processes are up to Edwards’ and industry standards, with a forward look toward compliance to ISO and other regulatory standards.
- Serve as a subject matter expert in the area of process development for the broader Edwards organization with the ability to explain complex procedures and concepts in easy to understand terms in order to train and mentor peers and other employees.
- Establish plans to drive the completion of deliverables by utilizing project planning, risk analysis and other management tools to maintain a multiyear roadmap. Develop training and documentation materials and training materials for production to enable the seamless knowledge transfer of project and manufacturing processes.
- Manage and/or oversee the work of assigned team within own function and/or cross functional project teams and may have some budgetary responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department.
- Work with Cross-Functional resources to define New Product Introduction Strategies.
- Work with R&D in the commercialization phase to execute the strategies for introducing new products and processes.
- Manage product phases activity around design, regulatory, quality and clinical requirements.
- Perform other duties and responsibilities as assigned.
- Bachelor’s degree in engineering with 10 years of combined manufacturing and leadership experience.
- Experience working in a regulated industry preferred.
- Certification six sigma.
- Proven expertise in usage of MS Office Suite; CAD experience preferred.
- Demonstrated track record in management of technical and/or engineering disciplines.
- Ability to manage technical and/or engineering disciplines and demonstrated informal mentoring and/or peer leadership skills.
- Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making.
- Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
- Ability to translate complex and technical information to all levels of the organizations through excellent collaboration, negotiation, teamwork and leadership skills.
- Expert knowledge and understanding of principles, theories, and concepts relevant to Engineering.
- Expert understanding of processes and equipment used in assigned work.
- Technical knowledge in manufacturing disciplines preferred, as are extrusion, injection molding, implantable devices and medical device in general.
- Demonstrated skill set to manage small team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations.
- Strong leadership and teamwork skills. Ability to influence change through negotiation and collaboration.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.