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.
Main Objective of the Position
Support the development, remediation, and continuous improvement of medical device packaging systems with emphasis on EU MDR implementation, manufacturing process support, and packaging cost optimization initiatives . The role is responsible for identifying opportunities to improve packaging designs, materials, and manufacturing processes in order to reduce material usage, optimize packaging configurations, and achieve sustainable cost reductions while maintaining product protection, regulatory compliance, and quality standards.
This position supports the identification, planning, and execution of cost‑saving and value engineering projects , including evaluation of alternative packaging materials, design optimizations, supplier changes, and manufacturing process improvements. The role collaborates with cross‑functional partners including Manufacturing, Quality, Regulatory Affairs, Supply Chain, and Sterilization Engineering to ensure packaging solutions support regulatory requirements and operational efficiency.
The position will also work closely with the Sterilization Engineering team to evaluate current and MDR‑driven packaging configurations , assessing packaging density, load configurations, and configuration applicability to ensure compatibility with sterilization processes while maintaining compliance with packaging performance and regulatory requirements.
Main Responsibilities
- Support EU MDR implementation activities including packaging and labeling updates for existing product portfolios.
- Review and update packaging drawings, specifications, and technical documentation to ensure compliance with regulatory and internal quality requirements.
- Coordinate packaging design changes related to UDI updates, labeling modifications, or regulatory remediation activities .
- Design, develop, and test packaging systems and sterile barrier configurations used for product protection and distribution.
- Execute and support packaging validation activities , including sealing process validations (PD, OQ, PQ) and distribution testing.
- Support design verification builds, packaging verification activities, and stability studies .
- Collaborate with the Sterilization Engineering team to evaluate packaging configurations, packaging density, and load configurations to ensure sterilization compatibility and regulatory compliance.
- Support manufacturing engineering activities , including troubleshooting packaging processes and improving manufacturing efficiency.
- Develop and update manufacturing procedures, work instructions, and packaging process documentation .
- Prepare and maintain packaging component drawings, specifications, and engineering documentation .
- Support supplier qualification activities , including preparation and review of PPAP documentation and supplier technical documentation.
- Work with suppliers to review technical specifications, manufacturing capabilities, and packaging component requirements .
- Support supplier communication and negotiation activities related to packaging materials and cost‑reduction initiatives.
- Identify and support cost‑saving opportunities related to packaging materials, packaging configurations, and manufacturing processes.
- Participate in the planning, coordination, and tracking of packaging‑related projects , including MDR remediation and cost‑reduction initiatives.
- Investigate and resolve packaging‑related issues or customer complaints through root cause analysis and corrective actions.
- Collaborate with cross‑functional teams including Manufacturing, Quality, Regulatory Affairs, R&D, Supply Chain, and Sterilization Engineering.
Requirements
Education
Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, or related engineering discipline .
Experience
- Minimum 2 years of relevant engineering experience in area
Technical Knowledge
- Knowledge of packaging materials, packaging design principles, and sterile barrier systems .
- Understanding of ISO 11607‑1 and ISO 11607‑2 requirements for medical device packaging.
- Familiarity with distribution testing standards such as ASTM D4169 .
- Understanding of EU MDR regulatory requirements impacting packaging and labeling .
- Experience working with engineering drawings, technical specifications, and document control systems .
- Familiarity with PPAP documentation and supplier qualification processes .
- Knowledge of Good Manufacturing Practices (GMP) and regulated manufacturing environments.
- Basic knowledge of statistical tools such as Minitab or similar data analysis tools.
Skills / Competencies
- Packaging design and validation
- Manufacturing engineering support
- Technical documentation and drawing updates
- Supplier technical communication and collaboration
- Cost reduction and value engineering
- Root cause analysis and problem solving
- Cross‑functional collaboration
- Project planning, task prioritization, and timeline management
Preferred Qualifications
- Experience in medical device or other regulated manufacturing industries .
- Experience supporting MDR remediation or regulatory compliance initiatives .
- Experience working with packaging suppliers and packaging manufacturing processes .
Experience supporting or coordinating engineering projects, including planning activities and milestone tracking .
TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
DIFFERENTIATING FACTORS
Autonomy: Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones.
May have some involvement in cross functional assignments.
Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex.
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts.
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Required Knowledge and Experience: Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.
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.
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here
