Packaging Engineering Program Manager

Medtronic - Santa Ana, CA (30+ days ago)4.0


Careers that Change Lives
Impact patient outcomes. Come for a job, stay for a career.

The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional,
collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to
address the needs of customers and patients across the globe.

As a Packaging Engineering Program Manager, you will ensure well defined planning and execution of packaging engineering
deliverables in new product development programs (PDPs). Proactively identify innovation and improvement opportunities in
packaging and labeling areas or business processes to improve quality, cost, delivery, compliance, as well as to ensure
alignment to industry requirements and GP&L Strategic Plan.

In order to be successful in the role, you will have a strong technical background in packaging engineering, deep understanding
of project management & risk management techniques, broad cross-functional knowledge. Self-directed manager with the ability
to lead teams, take initiative and be accountable for results. Must be team oriented with the confidence, maturity and
integrity to lead effectively. The incumbent will provide input to establishing program objectives, timelines, milestones,
and budgets.

A Day in the Life-
  • Be the Packaging and Labeling core team representative on critical PDPs. Lead the extended packaging and labeling
team and interface with R&D and Operations teams as needed.
  • Ensure well defined planning and repetitive execution of packaging engineering and labeling deliverables.
  • Ensure application of standardized project management and risk management methodologies across all packaging projects
to ensure consistent execution and delivery.
  • Drive resolution to project challenges through information exchange, influence and active persuasion to gain
cooperation of business partners on program execution plans.
  • Champion site-level key performance indicators (KPIs) including IDEAS/ Innovation/ Improvements.
  • Lead transition / integration of innovation team ideas to PDP readiness. Act as technical expert developing and
executing plans to drive down risk for future PDP programs.
  • Work with cross-functional team members to ensure clear internal and external communication of project/program
objectives, deliverables, and timing of key milestones.
  • Coach and monitor staff on robust Design Development, project management, DRM, risk burn down.
  • Drive strong connection to R&D and GP&L Innovation in leveraging key competencies during early phase PDP and VOC best
practices for the team.
  • Champion and coach on robust process validation from equipment selection, characterization, OQ, through PQ.
  • May lead key strategic projects in Packaging to align with GP&L Strat Plan (focused on cost, quality, compliance,
delivery and innovation)

Must Have: Minimum Qualifications
  • BS in Packaging or related engineering field (e.g.Mechanical or Materials)
  • 5+ years of project management experience (including cross functional team members)
  • Medical device or Pharma packaging experience
  • Knowledgeable in ISO, ASTM, ISTA standards related to packaging
  • Solid proficiency in MS Word, Excel and statistical analysis software
  • Familiarity with FDA quality assurance requirements for design and manufacturing.
  • Ability to travel domestically and internationally 25- 50% of the time
Nice to Have
  • MBA or Masters Degree in related technical field
  • People management experience
  • 5 years of experience with MDT business processes and systems
  • Certified Packaging Professional (CPP)
  • Project Management Professional (PMP)
  • Experience with ISO13485 and Design Control is
  • Experience with class II and III medical device product development teams
  • Experience with ethylene oxide, steam, liquid chemical, and radiation sterilization methods
  • Experience with Design for Lean Sigma (DFLS), Design for Manufacturability (DFM), process development and design of experiments (DOE) methodology
  • Experience with Design Verification and Process Validation
  • Experience with sterile barrier sealing equipment and processes
  • Experience with Minitab, Microsoft Project, Solid Works, CAD, Agile, and SAP software
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.