Senior Packaging Engineer - Cardiac Surgery

Medtronic•Brooklyn Park, MN

5d•Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. Our Cardiac Surgery Packaging Engineering Team is committed to excellence, innovation, and collaboration, working at the intersection of engineering rigor and real-world impact. We are looking for someone who brings not only strong technical expertise in sterile packaging design, materials, and validation strategies, but also curiosity, ownership, and enthusiasm to continuously improve and challenge the status quo. We are seeking a passionate and driven Packaging Engineer to join our team and play a critical role in advancing sterile barrier solutions for life-changing medical devices. In this role, you could either assess current designs or design new robust packaging systems, including pouches, trays, and other sterile formats, to ensure product integrity, patient safety, and regulatory compliance. We're working onsite 4 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In your role, you will work at the Brooklyn Park, Minnesota location. The Senior Packaging Engineer ensures the compliant, timely, and cost-effective implementation of packaging changes for released products across the portfolio by managing sustaining packaging updates such as design and supplier changes, CAPAs, cost reduction initiatives, and SOGL activities. The position supports remediation and compliance initiatives, including audit and regulatory submission support, standards impact assessments, reviews of new or revised regulations, tender requests, and field complaint investigations. In partnership with manufacturing sites and global distribution centers, the role resolves packaging issues by providing tier process support for package design and packaging processes, consulting on repack line setup, and maintaining packaging specifications in alignment with applicable standards. We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communications to achieve long-term sustainable impact. Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world. Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to be a part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We encourage and support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare. Join us for a career in IT that changes lives. Medtronic is committed to fostering a diverse and inclusive culture. Check out the accomplishments of our Women in IT group! http://bit.ly/MedtronicWomeninIT

Requirements

4+ years of experience with a bachelor’s degree or 2+ years of experience with an advanced degree

Nice To Haves

Strongly Preferred: Experience in medical devices or highly regulated manufacturing industries.
Bachelor of Science in Packaging Engineering or other Engineering disciplines with 5+ years of experience (or 3+ years of experience with an advanced degree in Packaging Engineering).
Experience in biomedical materials, processing knowledge and medical packaging design procedures.
Core Knowledge In:
ISO-11607 (Packaging for terminally sterilized medical devices)
ISO-13485 (Quality Management Systems for Medical Devices)
Packaging materials & sterilization processes
Design Control Process/DRM
Root cause analysis technique
CAPA Management
6 Sigma and Lean Principles
Project Management Principles
Supply Chain
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

Support plant-driven packaging initiatives, providing technical expertise and developing all necessary documentation as required by ISO-11607.
Packaging initiatives include, but are not limited to, the following:
Manage sustaining packaging changes, including design updates, supplier changes, CAPAs, and cost reduction initiatives.
Evaluate "Released Product" changes potential impact to corresponding packaging design/configuration and act accordingly (i.e., re-design, lead necessary testing/evaluation, etc.)
Support remediation and compliance initiatives, including audit and regulatory submission support, standards impact assessments, regulation reviews, tender requests, and field complaint investigations.
Partner with manufacturing sites and global distribution centers to resolve packaging issues, providing tier support for package design, packaging processes, and repack line setup.
Develop and maintain sterile barrier systems, packaging components, assemblies, and specifications in alignment with applicable standards.
Assess materials, processes, and configuration changes to meet cost, manufacturability, and sustainability objectives.
Interpret regulatory and technical requirements and translate them into clear specifications, test methods, acceptance criteria, and controlled QMS documentation.
Lead and execute packaging verification and validation activities, including test planning, protocol execution, reporting, equipment support, and lab or floor execution.
Lead packaging workstreams on cross-functional teams, serving as a subject matter expert while tracking milestones, risks, deliverables, and driving continuous process improvement.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Health, Dental and vision insurance , Health Savings Account , Healthcare Flexible Spending Account , Life insurance, Long-term disability leave , Dependent daycare spending account , Tuition assistance/reimbursement , and Simple Steps (global well-being program).
Incentive plans, 401(k) plan plus employer contribution and match , Short-term disability , Paid time off , Paid holidays , Employee Stock Purchase Plan , Employee Assistance Program , Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

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