Senior Program Manager Regulated Medical Devices

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Disability Insurance

Life Insurance

Adoption Benefits

Parental Leave

401(k) with Company Match

Paid Time Off

Job summary

Integer Holdings Corporation in Plymouth, MA is seeking a seasoned Project/Program Manager to lead end-to-end product development projects in regulated environments. You will manage cross-functional teams across engineering, QA, regulatory, and manufacturing to ensure on-time, on-budget delivery and adherence to PDP, MTP, and TDP processes.

The role requires 7+ years in project management with at least 4 in regulated settings such as medical devices or pharmaceuticals, plus PM certification.

Qualifications

• Minimum 7+ years of experience, at least 4 in a regulated product environment like medical devices, pharma, automotive, aerospace.
• 3+ years in a project management capacity leading multiple projects and teams.
• Certification in Project/Program Management is preferred.

Responsibilities

• Adheres to all safety, environmental, security and quality requirements including FDA regulations and company procedures.
• Manage end-to-end projects set up and regularly updated in Oracle ERP; ensure forecasting accuracy.
• Ensure projects align with customer agreements, billing milestones and revenue recognition.
• Monitor budgets and scope changes; deliver within budget and on time; report progress to stakeholders.
• Plan and direct product development projects with cross-functional teams; hand off to receiving org.
• Prepare master plans, quotes, budgets, specs, and schedules; provide status updates.
• Establish KPIs and governance for project execution; mentor cross-functional teams.
• Act as primary escalation point for project-related service requests and meetings.
• Identify and implement business process improvements across PMO tools and practices.

Skills

Team leadership

Coaching

Critical thinking

Communication

Education

Bachelor’s degree in Engineering

Master’s degree encouraged

PM certification

Job description

Integer Holdings Corporation in Plymouth, MA is seeking a seasoned Project/Program Manager to lead end-to-end product development projects in regulated environments. You will manage cross-functional teams across engineering, QA, regulatory, and manufacturing to ensure on-time, on-budget delivery and adherence to PDP, MTP, and TDP processes.

The role requires 7+ years in project management with at least 4 in regulated settings such as medical devices or pharmaceuticals, plus PM certification.