Sr. Packaging Development Engineer (Finance)

We anticipate the application window for this opening will close on - 11 Apr 2025

Position Description:

Sr. Packaging Development Engineer for Covidien, LP located in Irvine, CA. Responsible for design, development and support of package systems for both existing and new sterile products along with non-sterile medical devices including components, assemblies, and labels from design concept through to implementation. Follow the packaging development process (PDP) to design, develop, and test a variety of containers used for protection, display and handling of medical devices. Establish equipment and packaging workflows for cell operating system (COS) production line. Navigate complexes of ISO, EN and FDA quality assurance requirements for design and manufacturing of packaging, following compliance to ISO 11607 (Package Validation Testing) and ASTM (American Society of Testing and Materials) standards related to packaging. Utilize Test Method Validation [TMV], Statistical Process Control [SPC], Design of Experiments [DOE], Geometric Dimensioning & Tolerance [GD&T] and Corrective and Preventive Actions (CAPA). Conduct risk assessments to include DFMEA & PFMEA for packaging. Responsible for Process & equipment validations with a focus on process characterization Operational Qualification and Performance Qualification (OQ/PQ) per ISO11607-2. Coordinate packaging deliverables for regulatory submission and support sterilization optimization to reduce EO gas usage. Position works a hybrid model and will be onsite in Irvine, CA - 3-4 days per week. Relocation assistance is not provided. #LI-DNI

Basic Qualifications:

Masters' Degree in Packaging Engineering, Packaging Science, Industrial Engineering, Mechanical Engineering, or related engineering field and two (2) year of experience as a package engineer or related occupation in packaging engineering.

Must possess at least two (2) years' experience with each of the following: Packaging Development Process (PDP) to design, develop, and test a variety of containers used for packaging medical devices; Establishing equipment and packaging workflows for cell operating system (COS) production lines; ISO, EN and FDA quality assurance requirements for design and manufacturing and packaging, ISO 11607 (Package Validation Testing) and ASTM (American Society of Testing and Materials) packaging standards; Test Method Validation [TMV], Statistical Process Control [SPC], Design of Experiments [DOE], Geometric Dimensioning & Tolerance [GD&T], and CAPA; Conducting risk assessments to include DFMEA & PFMEA for packaging; Process & packaging equipment validations PV & OQ/PQ per ISO11607-2; and Packaging deliverables for regulatory submission and sterilization optimization. Position works a hybrid model and will be onsite in Irvine, CA - 3-4 days per week. Relocation assistance is not provided.

Salary: $108,200 to $141,600 per year

#LI-DNI

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: Medtronic benefits and compensation plans