The primary purpose of this role is to concurrently manage two or more (product) development and/or engineering projects of low to medium complexity across more than one site. You lead internal and external customers and cross-functional teams representing multiple functions to develop the defined deliverables for each project and then ensures the effective execution of those projects to the defined project budgets, timeliness, documentation, samples and shipments, and related activities. Key expectations for your role include directing team members, identifying and managing to project deliverables, project plans, risk assessments and appropriate risk mitigation activities to protect the project plan, and the required integrated schedule of critical activities to ensure all commitments are met. Additionally, you will be expected to identify and implement Program Management Office tools and best practices within a function, at a site, and/or across the enterprise.
Accountabilities & Responsibilities: • Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. • Responsible for end-to-end management and execution of multiple projects of varying complexities, ensuring that all projects are:
o Set up and regularly updated in the Oracle ERP system o Accurately forecasted o Adherent to customer agreements, billing events, & milestones o Financially tracked in accordance with established standards for cost management and revenue recognition aligned to Non-recurrent Engineering (NRE) and/or sales of sample, prototype, or verification units • Accountable for completing each assigned project within budget and on time, meeting key performance objectives, managing issues to resolution, managing project and scope changes in alignment to what was quoted or agreed to. • Partner closely with cross functional leaders to plan, develop, and direct product development and/or engineering projects from inception through successful implementation and hand-off to the designated receiving organization. • Prepare, monitor, and ensure adherence to master project/development plans, quotes, budgets, specifications, and schedules, providing periodic status reports as required for all assigned projects. • Establish Key Performance Indicators, including milestones, as governance for project execution; provide organization, leadership, and guidance to project/program teams, serving as a member for those or other business teams, as assigned. • Serve as the primary point of escalation on respective projects. Receive and respond to requests for service or information for project related matters. Prepare for and participate in status meetings (internal/external), and provide updates on the various projects to Integer cross-functional management, external customers, and suppliers, as necessary. • Identify and recommend business process improvements to make the existing Program (Project) Management Office tools more effective and efficient; engage in best practice sharing across stakeholders and PMO functions across the enterprise, reflecting implemented practices into the PMO Manual. • Manage planning and communication with other functions (marketing, quality, regulatory, design assurance, manufacturing, etc.), as applicable, as it relates to project initiatives, policies, etc. • Ensure identified issues or risks related to any of the assigned projects are effectively resolved to represent the best interests of external customers and the patients they serve, internal customers and affiliated functions, and the overall Integer business. • Support Integer's commercial team in assessing and providing inputs to new opportunities and quote development, which may involve visits to customer and/or supplier sites to assess technical capabilities and requirements, as well as general project requirements. • Actively engage with and leverage the implementation and adherence to Product Development Process (PDP), Manufacturing Transfer Process (MTP), and Technical Development Process (TDP) systems, as applicable. • Provide mentoring and training to Associates within the cross-functional teams, or others, as required. • May manage up to 2 to 3 direct reports, engineers or technicians, ensuring establishment of Goals and Objectives and supporting their respective personal and professional development plans. • Performs other duties as required.
Education & Experience:
Minimum Education: Bachelor's degree in Engineering or related technical field preferred. Master's degree in business or technical field welcomed.
Certification in Project/Program Management from an accredited institution preferred.
Minimum Experience: 7+ years of experience, at least 4 in a regulated product environment like medical devices, pharmaceuticals, automotive, and aerospace in addition to 3 in a project management capacity having led multiple projects and project teams.
Knowledge & Skills:
Special Skills:
o Demonstrated ability to lead team activities.
o Strong ability to coach
o Advanced critical thinking & problem-solving skills o Strong communication, presentation, follow-through, and organizational skills o Ability to effectively work both vertically and horizontally across the organization and cross functionally
o Collaboration and conflict resolution skills
• Specialized Knowledge:
Knowledge of current FDA, ISO, MDD, and other related quality and regulatory system requirements that intersect with design control and product development activities
o Comprehension of product & process development engineering principles sufficient to allow participation in product and technology development program ideation, scoping, initiation, and execution Integer Holdings Corporation (ITGR) is one of the largest medical device outsource (MDO) manufacturers in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and portable medical markets.
Able to travel domestically and internationally, as required (up to 30% at times