Senior Director, NPI and LCM

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

The NPI and LCM Leader for the Delivery Systems Network provides enterprise level leadership by aligning R&D, Manufacturing, Quality, Supply Chain, Finance, Regulatory, and PEGs to execute delivery system strategy end to end. This role owns execution from concept through launch, global site transfer, and post launch sustainability. By serving as the single point of accountability, the leader in this role mitigates execution and regulatory risk, optimizes engineering resources, and guides critical trade off and escalation decisions impacting cost, schedule, quality, and long term platform growth.

• Direct team members and engineering activities with overall responsibility of developing systems, staffing, planning, budgeting, managing expense priorities, performance management, and working through managers to achieve results. Develop SMEs to ensure engineering knowledge continuity. Drive culture, engage staff morale, and ensure employees’ safety.
• Develop robust talent development and succession planning in alignment with functional growth strategies across own organization.
• Set and lead the implementation of strategic processes that align with key business strategies.
• Lead cross-functional groups to develop and provide product and process design recommendations that integrate into multiple product lines and/or systems with significant complexity.
• Responsible for proactively assessing and implementing strategies to ensure business continuity (e.g., material obsolescence, capacity limitation, master validation plans). Lead in identifying risk, developing complex mitigation strategies, defining alternative solutions, resolving issues, etc. in collaboration with cross functional groups.
• Collaborate with network leadership to develop operational strategy. Partner with cross-functional groups/resources to achieve tactical execution of business objectives.
• Plan and direct strategic program activities (e.g., VIP/value engineering, product engineering, process engineering, advanced engineering, core competencies) in collaboration with cross functional teams to meet business objectives and compliance standards (e.g., CAPA, audits, master validation plans), while employing technical design skills to re-design/design new products and/or processes. This includes prioritizing and selecting appropriate projects and initiatives while using engineering methods (e.g., SIX Sigma and LEAN methods).
• Collaborate and align with network and COE teams in driving standardized programs leveraging best in class practices.
• Lead the integration of new products and collaborate with NPI and R&D teams on product and process transfers.
• Drive a value stream mindset and culture of continuous improvement based on lean and Six Sigma principles and EW Production System (EPS).
• Other incidental duties

• Bachelor's Degree in a related field
• Experience in engineering
• Demonstrated track record in management of technical and/or engineering disciplines

• Experience working in the medical device industry
• Proven successful project management leadership skills
• Proficient in both Microsoft Office Suite and related systems
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of…