Senior Program Project Manager (Exp in Regulatory or Medical Device Industry)

Job Summary

Medical Devices Company

Responsibilities

• In charge of medium-large scale, moderate to high complexity product release programs with sub-projects that may be related to a variety of compliance requirements that span multiple functional areas.
• Accountable for timely global commercial release of key products.
• Develop detailed program plans and manage all aspects of execution.
• Develop detailed risk registers and manage risk mitigation plans.
• Understand international standards and regulations, align on compliance requirements and create clear steps required to release with cross-functional stakeholders especially Quality, Compliance Engineering and Regulatory Affairs.
• Accountable for developing project budget including capital expenditure, expenses, and headcount.
• Lead, direct, coach, and mentor Core Team members to maximize project success. Provide meaningful and significant feedback to functional leaders regarding the performance of Core Team members that is considered in annual performance evaluations.
• Work with functional leaders to ensure the appropriate Core Team resources are committed to the projects and contribute to the expected levels.
• Lead the team to prepare for Phase Gate and other Go/No-Go decisions by executive leadership, ensuring that decisions are informed by a balanced and clearly articulated representation of the relevant data.
• Leads cross-functional teams through problem resolution including root cause analysis and corrective action.
• Ensure effective and efficient regular formal and informal communications with the Core Teams using a variety of tools and channels.
• Communicates program updates to functional management and executive leadership.
• Ensures compliance with the company's global development process.
• Demonstrates program management best practices and contributes to improving the product development process.
• Ensures business and technical lessons are reviewed, learned, and disseminated.
• Independently determines and pursues courses of action necessary to obtain desired results.

Experience & Competencies

• Requires a bachelor’s degree in a technical field and a minimum of 8-10 years relevant experience in new product development program management of successful cross-functional leadership in a matrix organization.
• Have served as a team member for a minimum of 5-7 years in the delivery of a complex systems and solutions.
• MBA or MS strongly preferred.
• Experience in Med Tech or other highly regulated industries developing electromechanical / software systems is a must.
• Experience in bringing hardware/software combination solutions to market.
• Experience leading highly cross-functional teams.
• A proven track record of executing of all aspects of product development including requirements, design, development, verification and validation as well as other aspects (e.g. performance, security, usability, scalability, install-ability, supportability) relevant to the final commercialized product.
• Ability to simplify complexity and provide clarity for the team and leadership.
• Demonstrated analytical, decision making, prioritization and problem-solving skills.
• Demonstrated ability to manage conflicts and ambiguity to drive clarity and deliver results.
• Demonstrated ability to partner with functional teams to enhance systems and processes to support business goals.
• Critical thinking/analytical capability.
• Ability to work autonomously with minimal direction.
• Excellent interpersonal, communication and negotiation skills for a wide variety of audiences, including senior management.
• Strong learning agility.