Position Description:
Sr. Packaging Engineer for Medtronic, Inc. located in Northridge, CA. Responsible for design, development, validation and support of packaging systems for both existing and new medical products and class-II/class-III devices including components, assemblies, and labels from concept through implementation; design package by utilizing Solidworks or Creo packaging design software; create component specification drawings and drive change mgmt. processes through ECOs (Engineering Change Orders). Perform packaging engineering in a regulated environment and release compliant packaging designs by navigating c-GMP (current Good Manufacturing Practices), 21CFR820, FDA quality assurance requirements for design and manufacturing and packaging; author package design validation plans, protocols, and work instructions; work with Quality to perform and support investigations on deviations and customer complaints related to packaging; conduct root cause analysis and implement CAPAs (Corrective Actions and Preventive Actions) 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; perform and/or support Process Validation (PV) by applying statistical techniques including Design of Experiment (DOE) methodology; coordinate packaging Design Validation (DV) activities and work with outside vendors on material selection. Develop EU-MDR (Medical Device Regulations) compliant packing for medical devices. Utilize Statistical Process Control (SPC); and author technical reports. *Position works a hybrid model and will be onsite in Northridge, CA - 3 days per week. #LI-DNI.
Basic Qualifications:
Requires a Master's degree or foreign equivalent in Packaging Engineering, Industrial Engineering, Mechanical Engineering or related engineering field and two (2) years of experience as a packaging engineer or related occupation; or a Bachelor's degree or foreign equivalent in Packaging Engineering, Industrial Engineering, Mechanical Engineering or related engineering field and four (4) years of experience as a packaging engineer or related occupation. Must possess a minimum of two (2) years of experience with each of the following: Medical Product or Packaging engineering compliant to c-GMP, 21CFR820, FDA quality assurance requirements, and EU-MDR; authoring test protocols; Solidworks or Creo packaging design software; DOE; DFMEA & PFMEA methodology; SPC, Root Cause Analysis, and CAPA; and creating component specification drawings and driving engineering change mgmt. process. *Position works a hybrid model and will be onsite in Northridge, CA - 3 days per week.
Salary: $113,100 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 settingis 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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