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Process Development Engineer

Company: Eliassen Group
Location: Providence
Posted on: March 15, 2023

Job Description:

Job DescriptionWe have an excellent job opportunity available as a Process Development Engineer!

Our role is expected to last 12 months

Responsibilities of the Process Development Engineer:

  • Design and develop equipment, processes, and control systems used for production and assembly of cell encapsulation devices
  • Manage the evaluation and selection of new equipment/technologies or modifications to existing systems to consider new processing technologies
  • Support ongoing optimization and improvement in equipment/systems/processes for long term robustness and reliability
  • Establishes operating specifications, defines process windows, and improves manufacturing techniques/processes
  • Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement
  • Write and report protocols, reports, SOP's, and work instructions, as required, and conduct or coordinate testing and execution of identified activities -
  • Design 3D CAD models, create drawings, and collaborate with vendors to produce prototype and production parts
  • Perform engineering analyses and relevant physical testing on designs
  • Provide hands-on troubleshooting, process, and manufacturing assistance in support of a rapid development cycle and manufacturing sustainability
  • Execute assigned duties on time and within budget; proactively telegraph delays and other issues to relevant stakeholders
  • Comply with all regulatory, corporate, and Quality System policies
  • Support Deviation Management, CAPA, and Change Control activities, as requiredRequirements of the Process Development Engineer:
    • BS or MS in Engineering or another relevant discipline
    • 5+ years of experience (3+ years with Masters) working on process development and optimization within a medical device environment or other GMP regulated industry
    • Experience leading and managing new process development initiatives from concept through execution, including process documentation and process qualification
    • Ability to coach and train less experienced engineers
    • Understanding of cGxP principles and practices and familiarity with ISO 13485, ISO 14971, and 21CFR820 is a plus
    • Knowledge of global cGMP requirements governing device or combination products
    • Experience with 3D CAD software, preferably with SolidWorks, is preferred
    • A strong understanding of statistical principles is required, as are strong technical writing and presentation skills
    • Hands-on approach to problem solving, risk identification and resolution. Six-sigma Green Belt / DMAIC problem solving experience preferred
    • Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously
    • Sense of urgency, ability to act/escalate promptly, and transparently communicate issues to involved stakeholders and management
    • Must demonstrate strong interpersonal, presentation, and teamwork skillsPlease be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an email address and never provide personal or financial information to anyone who is not clearly associated with EG Life Sciences. If you have any indication of fraudulent activity, please contact ID: 375174About EG Life Sciences:Founded in 2010, EG Life Sciences is a national professional services firm that delivers strategic consulting and innovative solutions for the pharmaceutical, biologic, medical device, and diagnostic industries. We provide tailored services to clients seeking to manage challenges, improve time-to-market, and fine-tune clinical development and operations. Our team is comprised of dedicated professionals and FDA-regulated industry specialists, each averaging over 20 years of related experience. This combination of services and team members enables us to quickly deliver value-driven life sciences consulting, project management and leadership, and customized project-based solutions.Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!

Keywords: Eliassen Group, Providence , Process Development Engineer, Engineering , Providence, Rhode Island

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