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MDR - Packaging Engineer

MDR - Packaging Engineer

ApTaskNew Haven, CT, United States
3 days ago
Job type
  • Full-time
Job description

About Client :

The client is a leading global IT services and consulting company that helps organizations manage and modernize mission-critical systems, integrate digital solutions, and drive innovation. It delivers services in cloud, security, analytics, applications, and IT outsourcing. With operations in over 70 countries, the company partners with major technology providers such as Microsoft, AWS, and Google Cloud to support digital transformation. The company serves diverse industries including healthcare, banking, insurance, manufacturing, and government, focusing on improving business performance and customer experience.

Salary Range : $65K-$70K / Annum

Job Description & Skill Requirement :

Must Have :

  • Medical device design, development & manufacturing, experience of products with electrical functionality an advantage
  • Examples of critical thinking and proven project execution
  • Leading a cross functional teams and leveraging solid PM skills e.g. project planning, communication, risk management, etc. Work collaboratively and with respect & humility with a cross functional team to drive project execution for medical devices, prioritizing safety, quality service, on-time execution.
  • Lead team to define goals, provide solutions and align on path forward, drive / track / communicate progress, adapt as needed with team.
  • Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures.
  • Use scientific problem solving methodologies e.g. DMAIC, process map.
  • whys, Is / Is not, etc. Drive solid decision making.
  • ttention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and / or data, within safety / scope / schedule / cost guidance).
  • Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges
  • 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.

Nice to Have :

  • Change control of Medical Devices
  • Equipment Commissioning / Qualification
  • Process Validation
  • Computer System Validation (CSV)
  • Manufacturing, Packaging and Laboratory Equipment
  • Technical experience (Trouble shooting) or any similar experience or background
  • Quality / Process Control / Assurance of Medical Devices
  • Responsibilities :

  • The role will include managing OEM Packaging opportunities for distributed products and / or development of sterile and non-sterile case and tray packaging for spinal implants and instruments.
  • This includes the Design History File documentation to support the development activities.
  • 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, 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
  • Top 3 technical skills that are required for the role :

  • CREO drawing software
  • Sterile Packaging / Medical Device Packaging Development
  • Project Management skills, including MS Project timeline and design history file management
  • Years' Experience Required : 2yr required; however, 4 to 7 years of experience preferred.
  • Non-benefitted (other than those mandated under state or federal law).Please note that this position does not include paid time off benefits. ApTask offers subsidized insurance coverage to our employees.

    About ApTask :

    ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-certified company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development. As a member of the ApTask team, you will have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries. Join us at ApTask and be part of our mission to empower organizations to thrive while fostering a diverse and inclusive work environment.

    Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.

    Candidate Data Collection Disclaimer :

    At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.

    If you have any concerns or queries about your personal information, please feel free to contact our compliance team at businessexcellence@aptask.com

    Applicant Consent :

    By submitting your application, you agree to ApTask's (www.aptask.com) Terms of Use nd Privacy Policy , and provide your consent to receive SMS and voice call communications regarding employment opportunities that match your resume and qualifications. You understand that your personal information will be used solely for recruitment purposes and that you can withdraw your consent at any time by contacting us at 732-355-8000 or help@aptask.com. Message frequency may vary. Msg & data rates may apply

    About ApTask :

    ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-owned company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development. As a member of the ApTask team, you will have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries. Join us at ApTask and be part of our mission to empower organizations to thrive while fostering a diverse and inclusive work environment.

    Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.

    Candidate Data Collection Disclaimer :

    At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.

    If you have any concerns or queries about your personal information, please feel free to contact our compliance team at businessexcellence@aptask.com.

    Applicant Consent :

    By submitting your application, you agree to ApTask's (www.aptask.com) Terms of Use and Privacy Policy, and provide your consent to receive SMS and voice call communications regarding employment opportunities that match your resume and qualifications. You understand that your personal information will be used solely for recruitment purposes and that you can withdraw your consent at any time by contacting us at 732-355-8000 or help@aptask.com. Message frequency may vary. Msg & data rates may apply.

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    Packaging Engineer • New Haven, CT, United States

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