Program Manager - Supply Chain/Product Supply
Pay Period: Annual
Bonus: 15%
Report To: Manager, Instrument Manufacturing Systems
Replacement Position: Yes
Employment Type: Full Time
No. of Openings: 1
Degree Required: 4 Year Degree
Experience required: 10 + years
Travel Required: to 25%
Purpose:
The Product Supply Program Manager plans, organizes and coordinates Product Supply activities associated with
active PACE programs (Product and Cycle-time Excellence) in the development of diagnostic products for the
Diabetes Care Division. The Product Supply PACE Program Manager represents the Product Supply function on
key PACE Projects. This position will also provide technical and functional assistance to Product Supply
personnel serving on other PACE Project Teams. This position works to ensure that PACE Team goals and
commitments are met while at the same time ensuring that Product Supply needs, goals and objectives are also
met. Projects start with generation of a product proposal and include all stages of product development, product
qualification, manufacturing start-up and introduction to the market place. Products developed typically comprise
sensors, software, instruments, and/or ancillary products. The Product Supply Core Team Member must be active
participants in the PACE Project from the start of Phase 0 Development. Whenever practical, the PS PACE
Program Manager should be involved in Pre-Phase 0 activities as well. Projects will typically involve
Manufacturing tooling and/or Equipment Budget of $2 million and teams of 5 to 15 people.
Major Tasks of Position
 The incumbent will serve as Product Supply’s Core Team representative on at least one major product
development program and may be accountable for multiple programs concurrently. Supporting “ScaledPACE Projects” are also within the scope of this position
 On larger programs, the Product Supply PACE Program Manager will work closely with the PS
Leadership Team to ensure proper coordination and communication of all critical Product Supply
activities. The incumbent will update the PSLT on project status on a regular basis.
 Organizes and leads the Product Supply functional activities associated with product development
project. The incumbent develops the project’s Manufacturing and Validation plans consistent with the
PACE process.
 Responsible for ensuring that the product design requirements, as defined by the Core Team, will result in
a manufacturable and marketable product that will meet the schedule, budget, standard product cost, and
quality commitments.
 Lead the Product Supply Element Team(s) consisting of functional/departmental representatives
accountable for implementation of project objectives within their functions/departments.
 Regularly communicates project status and issues with functional managers in Product Supply at multiple
sites with consultations of the PS Leadership Team.
 With the project team (Core Team), prepare the project plan according to PACE guidelines. This plan
details medical objectives, specifications, schedules, and resources necessary to meeting project
requirements.
 Ensure products are developed to the established requirements in the project plan. Report progress against
the plan routinely to the PS Leadership Team with recommendations for corrective action, where
necessary.
 Identify and manage all issues which impact product manufacture, warehousing or distribution. Monitor
assigned resources, project cost and report status to functional manager and the PS Leadership Team.
 Works closely with the Product Supply and QA Technical Review Board (TRB) members to ensure full
communication of any outstanding manufacturing issues and to address questions and concerns Raised by
TRB members
 Responsible for preparation and assembly of documentation required from Product Supply for Technical
Reviews and Phase Reviews. Schedule and lead Product Supply functional reviews prior to, and in
preparation for, Technical Reviews.
 Responsible for the successful manufacture and validation of products by ensuring all manufacturing
documentation Is in place, control system completed as shown to be functional, product prototype has
been field tested for customer acceptance, regulatory approval is obtained, legal issues, patents and
trademarks have been satisfactorily addressed and initial market introduction product quantities made,
tested and ready for distribution following Phase 3 approval.
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Prepare a post development Manufacturing summary for each assigned project upon completion of
Technical Review 3 and market introduction.
Motivate and lead departmental Element Team personnel assigned to the project in order that they
become effective team players and work aggressively to meet team and individual goals and
commitments.
Provide performance review feedback to the functional managers for Element Team members playing key
roles in the success of the project.
The incumbent will often serve as a Technical Review Board (TRB 1&2) member for PACE Projects for
which they are not serving as the Product Supply Core Team representative.
Major Opportunities
The Product Supply PACE Program Manager is responsible for the generation of the Manufacturing Plan and for
the successful implementation of this plan resulting in the efficient and cost effective manufacture of a new
product. The Product Supply PACE Program Manager leads the PS Element Team(s) consisting of responsible
functional/departmental representatives. The incumbent must motivate people from cross-functional departments
to meet the established schedules to complete all the manufacturing development activities to produce a new
product.
The Product Supply PACE Program Manager is expected to help ensure that all PACE project plan requirements
are achieved and to ensure the product features meet anticipated customer needs. Within the scope of the project
plan, the incumbent is expected to manager project issues related to system or component manufacture to achieve
the project objectives.
Requirements
The Program Manager has:
 A minimum of BS degree in Life Sciences or Engineering
 A minimum of ten years of experience in applicable product or process development
 Experience in the consumer, medical device industry is a plus
 The incumbent is knowledgeable in one or more areas of product development and product manufacture
including instruments, reagents, and software
 The incumbent must be skilled in managing a cross-functional element team and must have excellent
influencing skills to lead individuals, for whom he/she has not direct reporting relationship
 The incumbent is skilled in planning and organizing to enable the generation of a realistic PACE project
manufacturing plan
 Good judgment is called for in this position to make difficult decisions where technical problems and
competition or resources can affect the project schedule and specifications
 The incumbent must possess excellent communication skills, both written and verbal, to interact
effectively with project team members and functional managers from all departments associated with
product development
 The Product Supply PACE Program Manager is proficient in the Microsoft Office Suite of programs,
including Microsoft PowerPoint for developing presentations, and also with Microsoft Project for project
scheduling
 Must have FDA experience.
 Medical Device and SAP experience is strongly preferred.
Key Figures: Annual Project Budget - $1-2 Million
Outside Development Contracts – up to $5 Million
Annual Project Capital Budget - $2 Million
We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base
salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive
opportunities as well as benefits coverage beginning on your first day of employment. We are committed to
helping our employees maintain a healthy balance between their responsibilities at work and home. You will be
eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences.
We are also committed to supporting your professional development through career ladders, training programs,
tuition assistance and professional association events.
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Candidate Must Have: Must have a Bachelor's Degree in Engineering or Life Sciences
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Must have a minimum of 10 yrs experience in product or process development/engineering in a
manufacturing environment
Must have FDA experience, medical device and SAP strongly preferred
Must be knowledgeable and experienced in 1 or more areas of product development with instruments,
reagents or software
Must have Project/Program management experience
Specific Relocation Details:
We offer a competitive relocation package; details will be discussed with the selected candidate
For more information, please contact Bridget Proctor [email protected] Reference NCMA CCC