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Position Description:

Sr. Packaging Engineer for Medtronic, Inc. Minneapolis, MN. Responsible for design, development, and support of package systems for both existing and new sterile implantable products (trans- catheter therapies) and non-sterile medical devices including components, assemblies, and labels from concept through implementation that include testing, sterilization, and manufacturing processes. Execute packaging engineering tasks for PDP’s (Product Development Process) by defining customer needs, conducting VOX (Voice of Customers), coordinate design phase reviews, executing TMV’s (Test Method Validations) and design V&V’s (Validations and Verifications) in compliance with ISO 11607. Perform packaging engineering for a regulated environment and release package designs in compliance by navigating c-GMP (current Good Manufacturing Practices), 21 CFR 820, FDA quality assurance requirements for design and manufacturing and packaging. Author and execute package validations by testing protocols using ISTA (International Safe Transit Association), ISO 11607 (Package Validation Testing) and ASTM (American Society of Testing and Materials) standards related to packaging. Utilize Mechanical design software including SolidWorks, ArtiosCAD, PTC, and others, and statistical analysis software including MATLAB, Minitab, and others. Work with Quality to perform and support investigations on deviations and customer complaints related to packaging, conduct root cause analysis (RCA), and implement CAPAs (Corrective Actions and Preventive Actions) using Statistical Process Control (SPC) tools to ensure delivery of quality devices/products. Conduct risk assessments to include DFMEA & PFMEA (Design & Process Failure Mode Effect Analysis) for packaging, including packaging design and packaging process as required. Work with Quality and Operations to support Design for Lean Sigma (DFLS), Design for Manufacturability (DFM), process development and design of experiments (DOE) methodology. Perform and/or support Process Validation (PV) and Equipment Qualifications (IQ/OQ/PQ) and author technical reports. Utilize pallet design software to include TOPS or equivalent. *Position is open to telecommuting from anywhere in the United States.

Basic Qualifications:

Masters’ Degree or foreign equivalent in Packaging Science or Packaging Engineering or related field; and two (2) years of experience as a packaging engineer, manufacturing engineer, or related occupation for medical devices. Or alternatively Bachelors’ Degree or foreign equivalent in Packaging Science or Packaging Engineering or related field; and five (5) years of experience as a packaging engineer, manufacturing engineer, or related occupation for medical devices.

Must possess at least two (2) years’ experience with each of the following: Pallet design software; Sterile trans-catheter therapies and non-sterile medical device packaging design, development, testing, sterilization & manufacturing processes. SolidWorks, ArtiosCAD, PTC or equivalent software, and statistical analysis software; GMP, 21CFR 820, ISO 11607, and ASTM standards related to design and manufacturing and packaging; Risk assessments, DFMEA & PFMEA for packaging. Process & equipment validations, and IQ/OQ/PQ; SPC, RCA, and CAPA

Position is open to telecommuting from anywhere in the U.S.

Salary: $121,400 to $141,600 per year

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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 90,000+ 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.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world

• Grow a career reflective of your passion and abilities

• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

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