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Franklin Lakes

    Staff Packaging Engineer - Franklin Lakes, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences Franklin Lakes, United States

    3 weeks ago

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    Description

    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


    Responsibilities:
    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

    Detailed knowledge of ISO-(phone number removed) 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
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