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Product Development Engineer I
Product Development Engineer ICell and Gene Therapy • Quakertown, PA, United States
Product Development Engineer I

Product Development Engineer I

Cell and Gene Therapy • Quakertown, PA, United States
30+ days ago
Job type
  • Full-time
Job description

About the role :

The Product Development Engineer drives the design and development, validation, and commercialization of custom ordered textile components, including new designs, material conversion, process optimization, process qualification and quality compliance. Working regularly with the business team, clients, contract manufacturers, internal operation, quality engineering to deliver tasks and quality documents in accordance to the integrated product development process (IPDP).

What you'll do :

  • Lead and manage multiple projects for New Product Development in various stages of the product lifecycle in line with agreed commitments to respective clients.
  • Communicates to Management and Core team members of the status of assigned product development programs.
  • Develop textile designs utilizing textile design / engineering background and engineering principles, further advance textile components and develop finishing techniques as needed for client's end application.
  • Partners with a cross-functional team to facilitate a transition of manufacturing process from development groups to commercial groups per IPDP while maintaining collaborative working relationships.
  • Responsible for design of process that is scalable to a production environment based on client design and volume requirements.
  • Responsible for communicating manufacturing and process development status, expectations, and constraints internally and externally.
  • Responsible for documenting all phases per IPDP and quality compliance. Compile, maintain, review and interpret product development data.
  • Authors SOPs, Work Instructions, Batch Records, Product Specifications, Process Performance Qualification, Process Operational Qualification protocol plans and reports critical to Product development.
  • Supports Business managers to provide technical inputs to customers for early development programs and support Quality Assurance team with any non-conformance investigations as a subject matter expert.
  • Other duties and projects as assigned.

Who you are :

  • Bachelor's degree in Textile Engineering, Biomedical Engineering, Materials Engineering, or related discipline.
  • Experience in technical writing and use of statistical tools, including Minitab.
  • Proficient with MS Office.
  • Interpersonal skills with proven ability to get along well with others and work in a team environment is a must.
  • Strong analytical, critical thinking, leadership, and problem-solving skill is needed to manage technical projects.
  • What we offer :

  • Annual Bonuses
  • 401k (retirement savings) with excellent company match
  • Generous Paid Time Off
  • Health Insurance : Medical with Rx plan / Dental / Vision
  • Company Paid Life Insurance and Disability Plans
  • Why join us :

    We promote a collaborative, high energy, and fast-paced environment. Using fact-based data, our team members strive to constantly improve our processes and products. We nurture an environment where employees can creatively innovate solutions that drive impactful results both for the business and themselves.

    Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

    This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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    Product Development Engineer • Quakertown, PA, United States

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