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2018-04-232018-05-23

Principal Packaging Engineer

Medtronic
Santa Rosa, CA
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  • Job Code
    33647
Company Medtronic
Job Title Principal Packaging Engineer
JobId 33647
Location: Santa Rosa, CA, 95404, USA

Description
Principal Packaging Engineer

Location:

Santa Rosa, California, United States

Requisition #:

17000GNG

Post Date:

Sep 08, 2017

Principal Packaging Engineer

Careers that Change Lives

Be part of a dynamic GPL (Global Packaging and Labeling) organization that supports new product packaging development for Aortic, Peripheral and Coronary products developed in Santa Rosa and related acquisitions. The incumbent will design and develop novel sterile medical device packaging solutions for products such as Aortic Stent Grafts, Drug-coated Balloons and Drug-filled stents and will participate in GPL strategy projects. The role will lead and participate in high visibility teams comprising of functions such as RD, Operations, Regulatory, Quality, Supply Chain, Packaging and Labeling and other functions to ensure robust packaging development to support commercialization of products across the various manufacturing sites.

Impact patient outcomes. Come for a job, stay for a career.

As a Principal Packaging Engineer, you will be responsible for leading and managing the process for design, development, and support of package systems and processes for sterile medical devices including components, assemblies, and labels.

A Day in the Life-

• Works in a high visibility individual leadership role driving the new product packaging projects in both strategic and technical capacities.

• Represent packaging engineering function as a project lead on new product development teams.

• Accountable for the development and implementation of packaging for existing and new medical products and devices including class-II and class-III implantable products, drug/device combination products, and accessories.

• Leads the improvement and standardization of packaging on existing products with focus on performance and cost effectiveness.

• Actively collaborate with Packaging and Labeling peers within CardioVascular to identify and implement best practices, packages and processes.

• Participate on cross-functional, cross-site project teams focusing on packaging, packaging technology and processes improvements

• Utilize knowledge of FDA and ISO requirements related to packaging and labeling, ensuring robust package validation and qualification

• Draft technical documentation including package testing protocols and validation associated with the qualification and release of package designs

• Process development and support for packaging assemblies for manufacturing

• Develop plans to establish proof of shelf life, accelerated and real time.

• Coordinate projects and deadlines working with PL lead to ensure all new product and package improvement deadlines are met.

• Execute all aspects of packaging development and testing as required

• Serve actively in the identification of suppliers, testing and approving materials, including liaison with the vendors.

Must Have: Minimum Qualifications

• BS Packaging or related engineering field (e.g. Mechanical or Materials); and 7+ years of experience

• Medical device or Pharma packaging experience

• Knowledgeable in ISO, ASTM, ISTA standards related to packaging.

• Solid proficiency in MS Word, Excel and statistical analysis software

• Familiarity with FDA quality assurance requirements for design and manufacturing.

• Ability to travel up to 15%-20%, both domestic and international.

Nice to Have

• Certified Packaging Professional (CPP) preferred.

• Experience with ISO13485 and Design Control is preferred.

• Experience with class I, II and III medical device product development teams is preferred.

• Experience with ethylene oxide, steam, liquid chemical, and radiation sterilization methods

• Experience with Design for Lean Sigma (DFLS), Design for Manufacturability (DFM), process development and design of experiments (DOE) methodology

•Experience with Design Verification and Process Validation.

• Experience with sterile barrier sealing equipment and processes

• Experience with MiniTab, Microsoft Project, Solidworks, MatrixOne, Agile, QAD. and SAP software.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

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.

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.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.

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Medtronic
Santa Rosa, CA

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