Director Engineering, New Product Development

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

• Provide technical leadership and manage a team of manufacturing engineers to lead the development, qualification, and transfer of manufacturing processes to successfully commercialize new products in the Surgical Business Unit.
• Advance engineering activities from early product development through product launch while ensuring that manufacturing processes are developed that fully meet the operational needs for commercial success.
• Act as a liaison between R&D, supplier development, Global Supply Chain (GSC), quality, and sustaining operations to ensure readiness to seamlessly plan, source, make and deliver the product to customers around the world.
• Partner with New Product Introduction Managers, Pilot and Sustaining Operations, and Edwards manufacturing global locations to ensure successful outcomes towards the development, scaleup and transfer of manufacturing operations including the development of harmonized validations strategies and attainment of stability metrics. Drive line and capacity expansion plans in manufacturing locations in collaboration with demand planning and commercial groups for uninterrupted product supply.
• Provide technical leadership for the Surgical business unit’s manufacturing engineering (ME) team for successful process development, design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN, cGMP, EH&S guidelines, supplier development and process validation.
• Manage/oversee the work direct reports within own function and/or cross functional project teams. Support the development of PMOs and individual development plans (IDPs) for the team. Develop a robust talent development plan in alignment with functional growth strategies of the individual and the department.
• Plan and manage project activities (e.g., VIP/value engineering, COGS reduction activities, process improvement, etc.) with accountability for successful completion of all deliverables to the business. Where appropriate develop project plans, schedule, scope, and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods).
• Perform other duties and responsibilities as assigned.

What you’ll need (Required):

• Bachelor's Degree in engineering or scientific discipline.
• Minimum of 12 years of manufacturing operations experience with five of those years in the product development process and introduction of new products into supply chain in the medical device industry.
• Minimum of 5 years having people leadership experience including leading cross functional teams.
• 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.
• Experience in preparing for and presenting project status to executive leadership, including the development, and managing of dashboards.
• Ability to set clear expectations and orchestrate all Operations activities related to planning, sourcing, manufacturing, distribution, and associated functions. 
• Leadership and communication skills with extensive experience interacting and engaging stakeholders at multiple levels in the organization with track record of brand recognition and having established trust.
• Expert understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplines, and financial acumen as it relates to engineering.
• Global and Domestic travel of 15%.
• On-site requirement.

What else we look for (Preferred):

• Advanced engineering degree.
• Six sigma Black Belt certification.
• Experience in the medical device industry.
• Knowledge of design controls for Class II & III medical devices, including familiarity with one or more of the following: implantable NiTi, CoCr & tissue, mechanical devices, catheter-based delivery system.
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
• Experience in organizational change management possessing skills and ability to influence stakeholders, manage and socialize expectations, understand trade-offs and their impact, and mobilize cross functio