NPI & PLM Program Manager

The NPI and PLM Program Manager position is responsible for managing and implementing NPI and PLM changes in a fast-paced Instrument Operation team. The primary responsibilities will be focused on processes, standard work, data integrity, compliance, system administration, NPI planning and scheduling, and Operations support. Additionally, the role is the primary communication and process development owner between sites representing the activity in Penang, Malaysia. The role requires a quick turnaround time and providing key feedback to the stakeholder(s).

This position is part of the Global Instrument Operations and Global Supply Chain Organization. This position is located in Penang, Malaysia and will be an on-site role.

While the role is officially under Pall—the Danaher legal entity operating in Malaysia—it is dedicated exclusively to supporting Cepheid’s business. Like Pall, Cepheid is one of Danaher’s 15+ operating companies.

In this role, you will have the opportunity to:

• Manage the NPI and Sustaining qualification activity and develop processes to schedule, align material supply needs, and schedule priority within the Instrument Operations to ensure the committed deliverables.
• Lead product lifecycle changes related to ECO (Engineering Change Order) management with precision and timeliness, including change plans, change requests, and policy compliance. Review, create, and configure BOM (Bill of Materials) structures, and manage user and supplier master data.
• Analyze collected data and present actionable recommendations to improve ECO cycle efficiency through the leadership of an ECO Change Control Board.
• Collaborate closely with the MFG Engineering team to investigate product and process issues, resolve Change Orders, and implement materials management updates—assessing change impacts, planning materials, and managing dispositions at the Contract Manufacturer under a NPI Pilot Line environment.
• Coordinate with the Supply Chain Operations and Supplier Quality Engineering to align part and supplier qualification status with the approved supplier list and ensure consistency to the PLM (Product Lifecycle Management) documentation.

The essential requirements of the job include:

• Bachelor’s degree in Business Administration, Operations Management, or other applicable major with 5+ years of related work experience OR Master’s degree in the field with 3+ years of related work experience.
• Experience managing engineering requests for change and order implementation (change requests, change orders, and notifications)
• Experience in creating/configuring/analyzing BOM structuring product data, and specification ensuring compliance with relevant industry standards, regulations, and internal policies
• Must have strong understanding of Product Lifecycle Management and associated software experience: Agile / Windchill / Arena / SAP / Oracle
• Must be able to effectively communicate with and influence cross-functional teams

It would be a plus if you also possess previous experience in:

• Experience and knowledge of ISO/FDA-regulated industry
• Experience in process improvement within the change management process and managing a multi-site team within an outsourced manufacturing setup
• Experience in monitoring key performance indicators (KPIs) and report on performance metrics
• Excellent analytical and problem-solving skills
• Medical Products industry experience

Pall Corporation, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.