The Senior Engineering Program Manager (CTOR) represents Operations on New Product Development (NPD) Core teams. The CTOR is responsible for the overall Operations functional aspects in the CRHF/CAS business including value stream selection, planning, execution, and successful implementation of activities in the development and introduction of new products. The CTOR is the primary Operations interface to the cross-functional Core Team.
The candidate will own and ensure overall Operations project execution with respect to schedule, budget, resource allocation, risk management, issue resolution and compliance to internal quality requirements. Results are accomplished by leading up to 10 Extended Operations functions including Supply Management, Component Engineering, Process Development, Contract Manufacturing, Self-Manufacturing, Pharma Operations, Packaging & Labeling, Sterilization, Global Supply Chain, Distribution functions.
A Senior PD Program Manager in the CTOR role is responsible for medium to large scale programs with a high degree of program complexity, ambiguity, and political environment. A successful candidate will need to navigate ambiguity, develop strategy, provide focus, establish a plan, and guide team execution. Guidance from peers/stakeholders is limited because most situations are novel and innovative.
A successful candidate will be able to advance the organization by developing new best practices and lead meetings with internal/external customers. Influential communication to many levels of management is required in this role. Must be able to influence across functions and businesses to balance risk and divergent objectives. Gain the cooperation of other functions on program objectives and plan execution.
Program Management and Business, Strategic & Financial Acumen
• Lead the Operations Extended Team (up to 9 functions) to ensure on-time and on-budget performance.
• Ensure scope and execution alignment between operations and core team functions.
• Follow Ideation to Market Release business & international compliance processes for New Product Development
• Accountable for Operations technical, program and market risk management.
• Perform traditional project management responsibilities for resource, schedule, and funding needs.
• Create strategic solutions to meet anticipated patient and business needs with predictability and certainty.
• Strong financial acumen for people, direct expense, capital, free cash flow, inventory and operations finance.
• Skilled negotiator with demonstrated ability to create mutually beneficial results
• Experience in two or more of the 10 Extended Operations functions (Supply Management, Component Engineering, Process Development, Contract Manufacturing, Self-Manufacturing, Pharma Operations, Packaging & Labeling, Sterilization, Global Supply Chain, Distribution).
• Determine optimal integration for Operations function tasks through the new product development cycle.
• Leverage cross-functional relationships
• Develop Operations Strategy & execution plan across the Extended Operations team.
• Anticipate Operations needs and prevent challenges.
• Ensure Design, Reliability, and Manufacturability (DRM) scientific practices are consistently and rigorously applied [Design for Six Sigma, Lean Manufacturing or Six Sigma are similar concepts]
• Advance the technical capability of the department.
• Provide coaching and critical thinking to extended team & core team for problem-solving and technical rigor for DRM
• DRM Black Belt Certified (preferred requirement)
Communications & Influence
• Active and effective listening to what is being said to identify what is missing and close gaps.
• Leadership and influence between business leaders, functional leaders, Core Team and Extended Operations Team.
• Clear, concise, and simplified written and public speaking communication delivered with confidence and expert authority.
• Coach and develop peers and extended Operations members, to help individuals advance their skills and careers. Provide performance feedback.
• Recognize teams and individuals for exceptional performance
Must Have Qualifications:
• Proven Operations leadership with a strong background in at least two Operations functions, and Program Management experience
• Experience working in a highly regulated industry (e.g. medical device, pharmaceutical, avionics, automotive)
• Experience with problem-solving methodologies
• Experience leading virtual teams
• Experience in new product development
• Bachelor’s degree in a technical field such as Industrial Engineering, Mechanical Engineering, Material Science, Chemical Engineering, or related technical discipline.
• With BS: 7+ years with operations or program management experience
• With MS: 5+ years with operations or program management experience
Nice to Have:
• Advanced degree in an Engineering discipline or Masters in Business Administration (MBA)
• Experience with medical device products and therapies.
• Medical device product development experience and a strong understanding of FDA, ICH and IEC standards
• Experience across the entire product lifecycle
• DRM, DFSS, or Six Sigma Black Belt Certified
• PMP Certified
Internal Number: #20000CAW
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