At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

Main Objective of the Position

Support the development remediation and continuous improvement of medical device packaging systems with emphasis onEU 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 theidentification planning and execution of costsaving and value engineering projects including evaluation of alternative packaging materials design optimizations supplier changes and manufacturing process improvements. The role collaborates with crossfunctional 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 theSterilization Engineering team to evaluate current and MDRdriven 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

• SupportEU MDR implementation activitiesincluding packaging and labeling updates for existing product portfolios.
• Review and updatepackaging drawings specifications and technical documentationto ensure compliance with regulatory and internal quality requirements.
• Coordinate packaging design changes related toUDI updates labeling modifications or regulatory remediation activities.
• Design develop and testpackaging systems and sterile barrier configurationsused for product protection and distribution.
• Execute and supportpackaging validation activities including sealing process validations (PD OQ PQ) and distribution testing.
• Supportdesign verification builds packaging verification activities and stability studies.
• Collaborate with theSterilization Engineering teamto evaluate packaging configurations packaging density and load configurations to ensure sterilization compatibility and regulatory compliance.
• Supportmanufacturing engineering activities including troubleshooting packaging processes and improving manufacturing efficiency.
• Develop and updatemanufacturing procedures work instructions and packaging process documentation.
• Prepare and maintainpackaging component drawings specifications and engineering documentation.
• Supportsupplier qualification activities including preparation and review of PPAP documentation and supplier technical documentation.
• Work with suppliers to reviewtechnical specifications manufacturing capabilities and packaging component requirements.
• Supportsupplier communication and negotiation activitiesrelated to packaging materials and costreduction initiatives.
• Identify and supportcostsaving opportunitiesrelated to packaging materials packaging configurations and manufacturing processes.
• Participate in theplanning coordination and tracking of packagingrelated projects including MDR remediation and costreduction initiatives.
• Investigate and resolvepackagingrelated issues or customer complaintsthrough root cause analysis and corrective actions.
• Collaborate withcrossfunctional teamsincluding Manufacturing Quality Regulatory Affairs R&D Supply Chain and Sterilization Engineering.

Requirements

Education

Bachelors degree inPackaging Engineering Mechanical Engineering Industrial Engineering or related engineering discipline.

Experience

• Minimum2 years of relevant engineering experience in area

Technical Knowledge

• Knowledge ofpackaging materials packaging design principles and sterile barrier systems.
• Understanding ofISO 116071 and ISO 116072 requirementsfor medical device packaging.
• Familiarity withdistribution testing standards such as ASTM D4169.
• Understanding ofEU MDR regulatory requirements impacting packaging and labeling.
• Experience working withengineering drawings technical specifications and document control systems.
• Familiarity withPPAP documentation and supplier qualification processes.
• Knowledge ofGood Manufacturing Practices (GMP)and regulated manufacturing environments.
• Basic knowledge ofstatistical tools such as Minitabor 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
• Crossfunctional collaboration
• Project planning task prioritization and timeline management

Preferred Qualifications

• Experience inmedical device or other regulated manufacturing industries.
• Experience supportingMDR remediation or regulatory compliance initiatives.
• Experience working withpackaging suppliers and packaging manufacturing processes.

Experience supporting or coordinatingengineering 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 degreeand minimum of 2 years of relevant experience OR Masters 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.

Benefits & Compensation

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.

About Medtronic

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 95000 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