Packaging Engineer II

We need to output HTML fragment with sections: About the role? The posting includes description. We need headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. We have Pay: $45.00 - $55.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. So Pay section yes. Benefits: they say no Benefits, but supplemental package available. That's still benefits info? It says no Benefits, but ACA-compliant supplemental package available for enrollment. That is a benefit? Might be considered benefits. The rule: never create Benefits section unless posting actually states them. It does mention "no Benefits" and "ACA-compliant supplemental package available". That's still some info about benefits. I'd include Benefits section with that content. Schedule: not mentioned. No schedule info. So omit. About the role: we have description of role. Could put that as About the role. Responsibilities: there is a list of duties. Could extract responsibilities. Requirements: education, experience, etc. Qualifications: maybe overlapping with requirements. But we can combine? The instruction: prefer few substantive sections over many thin ones. Could combine Requirements and Qualifications? But they ask to use headings if content exists. We have content for Requirements (education, experience). Also Qualifications maybe "Must Have Skills" and "Nice to Have skills". Those could go under Skills. Thus sections: About the role (description), Responsibilities (list of duties), Requirements (education, experience, authorization), Skills (must have and nice to have), Pay, Benefits. We must not repeat job title as heading. No Job ID. We must use

for section headings. Use

• for any list of duties/requirements/benefits. Use

  for prose. We need to preserve all substantive information, not invent or summarize away detail. So we need to include details like contract length, location, etc. That could go in About the role paragraph. Let's extract: - Primary Talent Partners has a new contract opening for a Packaging Engineer II with our medical device client in Memphis, TN. This is a 24-month contract with a potential for extension. - Pay: $45.00 - $55.00/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: The role entails self-management of Packaging Development activities including design and quality deliverables involving: Strategy, Requirements flow down, Reviews, Roadmap Alignment, Design Inputs, Design Outputs, Design Characterization, Usability, Risk management, Manufacturing support, Design Validation, Labeling, Change Management, and Support Issues. Designs, develops, and creates test protocols/reports for 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, Operating Room Workflow, 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. Responsible for ensuring EU MDR Guidelines are met, and suggest where remediation steps may be needed. Update existing files to meet state of the art file expectations. - Top 3 technical skills that are required for the role: Medical Device Packaging Design (Sterile Packaging / Steam Sterilization Cases) Project Management skills, including timeline management and design history file ownership (Excellent documentation/reporting skills/file organization) CREO drawing software - Fully capable and comfortable with CREO - Education Required: Bachelor of Science in Packaging, or Mechanical Engineering, or Biomedical Engineering - Requires a Bachelor's Degree and minimum of 3 years of relevant experience, or advanced degree with 2 years of experience. - Years' Experience Required: Internship (2 to 7 years of experience preferred) - Responsibilities may include the following and other duties may be assigned: (list similar to earlier) - Must Have Skills: Design 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 Practices Experience with medical devices sterilization methods (i.e., ethylene oxide, radiation, etc.) Experience implementing appropriate risk mitigation actions with knowledge of packaging or process and process Risk Management as per FDA & ISO standards. Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools. Working knowledge of SolidWorks or other packaging CAD programs (i.e., TOPS, SolidWorks, CREO, etc.). Experience with Minitab or other statistical software. Medical Device Packaging Design and Process Development - Nice to Have skills: Experience developing Medical Device Case and Trays used with Steam Sterilization We need to avoid duplication. The responsibilities list appears twice similar. We'll combine into one responsibilities list. We must not include boilerplate like EEO etc. Now craft HTML. Structure:

  About the role

  Primary Talent Partners has a new contract opening for a Packaging Engineer II with a medical device client in Memphis, TN. This is a 24‑month contract with potential for extension. Candidates must be legally authorized to work in the United States and able to sit on Primary Talent Partners W2 without sponsorship.

  Responsibilities

  • Self‑management of Packaging Development activities including strategy, requirements flow down, reviews, roadmap alignment, design inputs, design outputs, design characterization, usability, risk management, manufacturing support, design validation, labeling, change management, and support issues.
  • Design, develop, and create test protocols/reports for a wide variety of containers used for protection, display, and handling of products.
  • Determine packaging specifications according to product nature, cost limitations, legal requirements, and required protection type, considering resistance to moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.
  • Design package exteriors considering product identification, Operating Room Workflow, 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.
  • Ensure EU MDR Guidelines are met and suggest remediation steps where needed.
  • Update existing files to meet state‑of‑the‑art file expectations.

  Requirements

  • Bachelor of Science in Packaging, Mechanical Engineering, or Biomedical Engineering (or equivalent).
  • Bachelor’s degree and minimum of 3 years of relevant experience, or advanced degree with 2 years of experience.
  • 2 to 7 years of experience preferred (internship level).
  • Legally authorized to work in the United States; able to work on Primary Talent Partners W2 without sponsorship.

  Skills

  Must Have

  • Design and development of a packaging system for terminally sterilized medical devices per ISO 11607‑1 and corresponding ASTM/ISTA standards.
  • Validation of processes for terminally sterilized medical devices per ISO 11607‑2 (forming, sealing, assembly).
  • Strong working knowledge of FDA Medical Devices Part 820 QSR & Medical Device GMP.
  • Experience with medical device sterilization methods (ethylene oxide, radiation, etc.).
  • Experience implementing risk mitigation actions per FDA & ISO standards.
  • Six Sigma/Design for Six Sigma experience or knowledge of Process Excellence tools.
  • Working knowledge of SolidWorks or other packaging CAD programs (TOPS, SolidWorks, CREO, etc.).
  • Experience with Minitab or other statistical software.
  • Medical Device Packaging Design and Process Development.

  Nice to Have

  • Experience developing Medical Device Case and Trays used with Steam Sterilization.
  But we only allowed

  for section headings, not

  . The instruction: use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It didn't forbid other headings, but to be safe we could avoid

  and instead incorporate Nice to Have as part of Skills list with a note. Could use

  • and within li include parentheses. Or we could make two subsections using

    but that would be many sections. Better to keep Skills as one section and include both Must Have and Nice to Have within list, maybe label them. We could do:

    Skills

    • Must Have: ...
    • Nice to Have: ...
    But each li would contain multiple sentences; that's okay. We need to preserve all details. Let's capture Must Have items as separate li? Could be many. We'll keep them as separate li for clarity, but we need to avoid using

    . We can just list them all as li, and maybe add a note "Nice to Have:" as a separate li. Thus:

    Skills

    • Design and development of a packaging system for terminally sterilized medical devices per ISO 11607‑1 and corresponding ASTM/ISTA standards.
    • Validation of processes for terminally sterilized medical devices per ISO 11607‑2 (forming, sealing, assembly).
    • Strong working knowledge of FDA Medical Devices Part 820 QSR & Medical Device GMP.
    • Experience with medical device sterilization methods (ethylene oxide, radiation, etc.).
    • Experience implementing risk mitigation actions per FDA & ISO standards.
    • Six Sigma/Design for Six Sigma experience or knowledge of Process Excellence tools.
    • Working knowledge of SolidWorks or other packaging CAD programs (TOPS, SolidWorks, CREO, etc.).
    • Experience with Minitab or other statistical software.
    • Medical Device Packaging Design and Process Development.
    • Nice to Have: Experience developing Medical Device Case and Trays used with Steam Sterilization.
    Now Pay section:

    Pay

    $45.00 – $55.00 per hour; W2 contract, no PTO, no benefits. ACA‑compliant supplemental package available for enrollment.

    Benefits section:

    Benefits

    No standard PTO or benefits offered; however, an ACA‑compliant supplemental package is available for enrollment.

    We should not repeat "no benefits" twice; but it's okay. Now ensure we didn't include any boilerplate. We omitted EEO etc. Now output only HTML fragment. Check for any