PackStaff, LLC
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The R&D Staff Packaging Engineer will impact health care and the MDS business groups by driving commercialization of new products and design changes for current products through development, qualification and launch phases.The R&D Staff Packaging Engineer contributes to building organizational effectiveness through creating, using and sharing standard processes; leading and mentoring others; seeking and providing training; driving technical and workflow innovation.Duties & Responsibilities
  • Subject matter expertise (SME) on packaging design for Class II and III medical device, pharmaceutical and combination products.
  • Technical leader of the design, development, and qualification of packaging systems for new and existing products. Independently develops and drives strategies for:
    • Design Development: Develops packaging designs, DOE’s, edge of failure analysis, process development and design verification.
    • Design for Manufacturability (DFM): Assess manufacturability, material selection, development of packaging processes for new or existing packaging systems.
    • Defining Packaging Requirements: Translate customers and regulatory needs into engineering requirements and specifications.
  • Leads multiple, complex, high-volume projects at one time.
  • Implement DFSS tools through the design selection and development process, deploying statistical and analytical tools.
  • Internal technical packaging SME and mentor for other packaging engineers
Education And Experience
  • A Bachelor’s degree in Packaging, Mechanical, Materials Engineering or a related Science/Engineering field is required. A post-graduate degree (MSc or PhD) is preferred.
  • A minimum of 8 years of experience in packaging of medical devices, pharmaceutical and/or combination products is required.
  • A demonstrated track record of technical influential leadership and delivering results
  • Excellent oral, written, and interpersonal communication skills
  • Ability to tactfully advise decision-maker
Required Knowledge and Skills:
  • Detailed knowledge of ISO-11607-1 and -2, ISO 13485, medical device packaging ASTMs, cGMP and medical device validation methodology
  • Packaging systems, medical device class II and III, design verification and validation experience for primary, secondary and tertiary; flexible and rigid packaging applications
  • Experience with different medical device package designs (i.e. FFS pouch, top lid rigid trays, pre-made pouches, etc)
  • Proficiency using solid modeling tools (SolidWorks preferred)
  • Proven experience on forming and sealing packaging processes
  • Experience using design for six sigma (DFSS) elements for packaging systems design and/or analysis
  • Statistical analysis using Minitab software (i.e. DOE, process capability, analysis of variances)
  • Understanding of sterilization technologies (i.e. radiation and gas) and their impact on medical device packaging
  • Proven expertise on technical critical thinking interpreting data results, demonstrating equivalency and/or technical rationales for medical device packaging design systems
  • Proven experience following medical device design control
Preferred
  • Experience on DOT, IATA and IMDG regulations for the shipment of hazardous materials
  • V&V experience for drug containers
  • Proven expertise in finite element analysis
  • Proven use of engineering first principles analysis
  • Container closure USP standard & WHO guidelines
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