R&D Packaging Engineer — Medical Device (Irvine, CA) Contract – Mid-level (Hybrid) - Pharmavise Corporation

Job Role: R&D Packaging Engineer — Medical Device (Irvine, CA) Contract – Mid-level (Hybrid)

Overview:

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at and follow us on LinkedIn:

Our Fortune 500 Medical Device client has an exciting opportunity for an R&D Packaging Engineer.

Job Summary:

The R&D Packaging Engineer is responsible for the development and analysis of Packaging for acquisition and integration activities. This role requires the candidate to function under limited supervision/ guidance, compiles to regulations and standards, performs analyzes, and documents test/ research data to establish performance standards for newly designed or modified packaging, products, processes, or materials.

Responsibilities:

·        Participate in due diligence and integration activities as appropriate.

·        Fully participates in and successfully contributes to project teams typically including the following activities: packaging/product design and development, test of materials, preparation of specifications, process capability studies, report preparation, and process/test documentation.

·        Ensures proposed packaging design changes are systematically and thoroughly analyzed through proper justification and/or data collection for verification of performance requirements.

·        Work independently to plan and schedule own activities necessary to meet project timelines.

·        Work cross-functionally with project management, quality, R&D, manufacturing, regulatory, operations, and marketing to ensure project success.

·        Work with external suppliers to design, qualify and procure packaging components.

·        Complete packaging testing and/or bench study experiments for commercial design improvements.

·        Participate in resource planning, and the development and implementation of new team members for supporting due diligence and integration activities. 

·        Generate packaging-related documentation including test protocols and reports.

·        Perform root cause analysis as related to design, material, or process failures.

·        Summarize, analyze, and draw conclusions from test results.

·        Design, procure, and fabricate tooling and fixtures.

·        As applicable, train technicians or operators on new processes or test procedures.

·        Identify areas for continuous improvement.

·        Keep abreast of new technologies and advances in the greater packaging industries.

Requirements:

·        B.S. degree in Packaging (but not required)

·        Minimum of 3 years of R&D Packaging Engineering experience (medical device related experience preferred)

·        Knowledge of ISO 11607 Part I & II, ASTM and ISTA Standards

·        Quality-driven with great work ethic, highly motivated, tenacious and meticulous in execution

·        Demonstrated problem solving capability

·        Strong communication skills (oral, written and virtual)

·        Ability to manage simultaneous projects and timelines effectively

·        Understanding of quality system controls (user needs, design inputs/outputs, design verification/validation, etc.)

·        Knowledge of paperboard, flexible packaging films, Tyvek, thermoformed trays, injection molded parts, MEE/ crates, returnable or reusable, temperature controlled, and packaging equipment.

·        Packaging process and equipment qualification experience

Other Details:

·        Schedule: 40 hours per week

·        Contract Length: 12 months

·        Set-up: Hybrid in Irvine, CA

EEO Employer:

Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact .

Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.

E-Verify Participation:

Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.