Sr Packaging Engineer

Primary Talent Partners has a new contract opening for a Sr Packaging Engineer with our medical device client in Lafayette, CO. This is an 8-month contract with a potential for extension. Pay: $55.00 - $65.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship. Description: Sr. Packaging Engineer supporting the CST business unit. This contractor will lead and support packaging-related work tied to manufacturing transfer, process validation, design verification in a regulated medical device environment. Day-to-day responsibilities include collaborating with R&D, manufacturing, quality, and supply chain teams; developing and executing packaging test protocols and reports; supporting validation and verification documentation; evaluating packaging changes and associated technical rationale; and ensuring compliance with FDA and EU MDR expectations. Responsibilities may include the following and other duties may be assigned: Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products.Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques.Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants. Must have skills:Change control of Medical DevicesEquipment Commissioning / QualificationProcess ValidationComputer System Validation (CSV)Manufacturing, Packaging and Laboratory EquipmentTechnical experience (Trouble shooting) or any similar experience or backgroundQuality / Process Control / Assurance of Medical DevicesDesign and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607-1 (Part 1: Requirements for materials, sterile barrier systems and packaging systems) and corresponding packaging ASTM and ISTA (International Safe Transit Association) standards.Validation of processes for packaging medical devices that are terminally sterilized as per requirements established by ISO 11607 2 (Part 2: Validation requirements for forming, sealing and assembly processes). These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing PracticesExperience in equipment IQ 2. Process Validation Lifecycle (from process characterization, OQ to PQ) ears experience with a BS Packaging or related engineering field or 3 years with MSSterile Barrier Testing Nice to have skills: 3D ModelingApplied Minitab analysiscost savings analysis Education requiredBachelor's degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field. Years' experience requiredTypically 5 to 8 years of relevant packaging engineering experience, with strong preference for experience in regulated medical device environments. Top 3 technical skills requiredPackaging engineering experience in regulated medical device or other regulated industriesManufacturing transfer, process validation, and design verification experienceWorking knowledge of FDA and EU MDR requirements, including technical documentation and justification support Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com #PTPJobs