Senior Program Manager – Regulated Medical Devices

Integer Holdings Corporation; Plymouth (MN); On-site; USD 137,000 - 202,000; Full time

Job summary

Integer Holdings Corporation in Minnesota seeks an experienced Project/Program Manager to lead end-to-end product development projects in regulated environments, ensuring compliance with PDP, MTP, and TDP processes.

You will coordinate cross-functional teams, manage scope, budget, and schedules, and ensure compliance with FDA/ISO requirements while partnering with customers and suppliers. Travel up to 30% domestically and internationally may be required.

Qualifications

• Bachelor's degree in engineering or related field.
• 7+ years experience in a regulated product environment.
• 4+ years in project management leading multiple projects.

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, 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 set up and regularly updated in the Oracle ERP system.
• Accurately forecasted and adherent to customer agreements, billing events, milestones; financially tracked for cost management and revenue recognition aligned to 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, and handling scope changes.
• Partner 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 with periodic status reports.
• Establish KPIs and governance for project execution; provide leadership to project/program teams; participate in status meetings with internal/external stakeholders.
• Identify and implement process improvements to make PMO tools more effective; share best practices across stakeholders and PMO functions.
• Manage planning and communication with marketing, quality, regulatory, design assurance, manufacturing, etc., related to project initiatives.

Skills

Team leadership

Coaching

Critical thinking

Communication

Cross-functional collaboration

Conflict resolution

Education

Bachelor's degree in engineering

Master's degree welcomed

PM certification

Job description

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers’ success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

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:
• Set up and regularly updated in the Oracle ERP system
• Accurately forecasted
• Adherent to customer agreements, billing events, & milestones
• 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, qu ality, 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 re quired.
  
  

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.
• Salary range: $137,000-202,000
  
  

Knowledge & Skills

• Special Skills:
• Demonstrated ability to lead team activities
• Strong ability to coach
• Advanced critical thinking & problem-solving skills
• Strong communication, presentation, follow-through, and organizational skills
• Ability to effectively work both vertically and horizontally across the organization and cross functionally
• 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
• Comprehension of product & process development engineering principles sufficient to allow participation in product and technology development program ideation, scoping, initiation, and execution
• Broad experience base with manufacturing processes across multiple products and processes, preferably inclusive of medical components, subassemblies and finished medical devices
• Able to travel domestically and internationally, as required (up to 30% at times)
  
  

Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.