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:

Project Leadership:

· Build and manage an integrated Master Transfer Plan (scope/WBS, budget, schedule, risks, communications) spanning sending and receiving sites; run phase gates from readiness, validation, launch, and stabilization.

· Chair cross functional meetings; maintain issue/risk registers and change control; publish monthly status and capital forecasts to leadership/PMO.

· Ensure alignment with corporate strategy, timelines, and budget.

Product Transfer & Ramp-Up

· Lead process transfer activities from sending sites to the receiving site, ensuring minimal disruption and excellent quality assurance.

· Plan and execute equipment de-install, crating/shipping, import clearance, re-install, hook up, and FAT/SAT; lead IQ/OQ/PQ protocols with Quality/Validation and vendors

· Drive operational readiness, including cleanroom, EHS, & facilities readiness; equipment installation, validation, and workforce onboarding.

· Ensure transfer deliverables satisfy ISO 13485 and FDA 21 CFR 820 requirements.

· Drive process/equipment validation strategy (URS, risk assessments, protocols/reports); support audits/inspections.

· Align component/tooling transfers, supplier readiness, and logistics (export from EU/US, import to MY) with build plans; manage inventory cutovers/SKU changes to protect service.

· Lead pilot, engineering, and pre-production builds, and output & yield stabilization; execute control plans and training; transition to sustaining with documented lessons learned.

Stakeholder Engagement:

· Act as the primary point of contact for internal and external stakeholders, including suppliers, contractors, and regulatory bodies.

· Provide regular updates to senior leadership on project status, risks, and mitigation plans.

Risk & Compliance Management:

· Identify potential risks and implement proactive mitigation strategies.

· Ensure compliance with local regulations, corporate standards, and industry best practices.

Education & Experience:

· Bachelor’s degree in engineering, Project Management, or related field (master’s preferred).

· Minimum 8–10 years of experience in project management within medical device manufacturing environment.

· Strong project controls (schedule, budget/capex, risk, stakeholder comms) and proficiency with PM tools (e.g., MS Project, Smartsheet, etc.).

· Preferred: PMP/Prince2 or equivalent; Lean/Six Sigma credentials.

· Proven track record in managing product/process/equipment transfers, or NPI to production, in medical device manufacturing,

· Leadership in Quality, RA, Manufacturing, Facilities, and Supply Chain in Medical Devices is an advantage.

· Strong knowledge of GMP, EHS, and regulatory compliance.

· Excellent leadership, communication, and stakeholder management skills.

Knowledge & Skills:

· Strong ability to coach

· 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

· 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 internationally, as required (up to 60% at times)

Performance Metrics:

· Project Delivery: Completion of product transfers and operational ramp-up within agreed timelines and budget.

· Quality & Compliance: Zero major non-conformances during audits and regulatory inspections.

· Cost Management: Achieve or exceed cost-saving targets without compromising quality or safety.

· Stakeholder Satisfaction: Positive feedback from internal and external stakeholders on communication and project execution.

· Risk Management: Effective identification and mitigation of project risks, resulting in minimal disruptions.

· Operational Readiness: Successful start-up of manufacturing operations meeting production and quality targets.

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