LifeScan, Inc./Calibra is currently recruiting a Director of Product Management, NPI, Life Cycle Management (LCM) and Component Engineering for the Wayne Pa or Aquadilla, PR. Site.
The Director, Product Management for OneTouch Via™ Wearable Patch Insulin Delivery will be responsible to lead and oversee the development, validation, and delivery of the components, automation, and all supply chain activities required to launch OneTouch Via™ product and to achieve our strategic plan for the business.
The Director Product Management, NPI & Life Cycle Management (LCM) and Component Engineering will need to exhibit excellence in influence leadership and will collaborate with Plant and Supply chain leaders across Plan, Source, Make, Deliver, Quality, and Advanced Engineering to leverage skills and capabilities to achieve franchise objectives. The position will collaborate with R&D to influence product designs to assure manufacturable designs are realized.
Primary responsibilities include: Lead and leverage a team of technical experts across the Diabetes care supply chain including Product Management, Make, and Advanced Engineering assure delivery of the full supply chain system for OneTouch Via™. Specifically responsible for delivery and validation of components through Product Management Components Engineering team and components suppliers. The position will collaborate closely with the Automation COE in the delivery of automation and test equipment including the low volume line, medium volume line, and high volume line. The position will have oversight to assure full characterization and validation of the process to produce OneTouch Via™ and assure robust and reliable supply. Partner with plant leadership to assure the optimized integration of the product into the plant and supply chain production systems. Lead the integration of the product flow into the end to end distribution network to assure effective delivery of the product to the customer. Lead delivery of critical LCM objectives. Accountable for overall Calibra supply chain capital budgets.
Provide transparent communication of project status, risks, and plans as appropriate at all levels and across the matrix. Collaborate with the PLT to assure the supply chain strategy enables the Calibra business strategy. Build and maintain a winning team. Overall, achieve the on-time launch for OneTouch Via™ and deliver priority LCM activities to stabilize and optimize the platform.
The position will be located in either Wayne Pennsylvania or Aguadilla PR. Significant time will be required in Aguadilla, Wayne, and Key supplier locations. 25% or greater travel expected.
Reports to: Sr. Director Product Management / PLT Lead / VSM LeadQualifications
- BS Engineering required. Preferred discipline: Mechanical, Material Science, Bio-Engineering, Chemistry, Electrical Engineering. Advanced Engineering Degree Preferred. MBA preferred.
- minimum combined engineering experience with minimum 5 yrs in product & process development within a medical device production environment is desired.
- Proven success in Engineering leadership and proven people leader with in combined direct reporting or matrix reporting people leadership is preferred.
- Previous experience in an R&D / Product Design and development is preferred.
- Design or Process Excellence experience required. Certification is preferred.
- Experience in US and International medical device regulatory processes. 510k, CE is required
- PMA, BLA or similar complex regulatory pathways is desired.
- Complex Project Management Experience
- Experience component design, development, and production processes
- Experience in Plastic injection molding and micro molding processes
- Proven success in new product development and introduction in Medical Device
- DFM / DFA / Concurrent Development Experience
- Systems and Automation Engineering Experience
- Discrete and Continuous process engineering
- Proven Technical People leader able to attract and motivate top technical talent and People development
- Comply / ensure compliance to all applicable safety and EH&S policies
- Financial acumen (Capital Management, P&L, Financial Statement analysis, Department Budget management)
- Strong business acumen including project business case development and market analysis
- Ability to explore and understand patient disease state
- In-depth understanding of applicable regulatory requirements
- Experience with / or understanding of 3D printing in supply
This position could require up to 25% travel both Domestic and International
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.Primary Location
United States-Pennsylvania-WayneOther Locations
North America-United States-Puerto Rico-AguadillaOrganization
Lifescan Inc. (6097)Job Function
New Product Intro-Life Cycle Mgmt