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Process Engineer I
Process Engineer Irestor3d • Durham, NC, US
Process Engineer I

Process Engineer I

restor3d • Durham, NC, US
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Job Description

Job Description

The Process Development Engineer will lead the design and development of the digital processes for manufacturing patient-specific products processes. This role requires extensive collaboration with cross-functional teams, including Digital Production, Product Development, Digital Automation, Technology Development and Information Technology, to develop efficient and quality driven production processes. The ideal candidate will have a strong background in biomedical or mechanical engineering, a deep understanding of CAD systems, and a proven track record of process improvement in a regulated environment.

Duties and responsibilities

  • Leadership & Collaboration : Serve as a key liaison between Digital Production and other departments, fostering strong relationships across the company and with external resources.
  • Goal Alignment : Understand the company’s objectives, responsibilities and mission, aligning work accordingly.
  • Planning and Adaptability : Prioritize and plan work activities to meet targets, adapting to changing conditions as needed.
  • Project Planning : Draft and maintain project plans to effectively communicate deliverables and targets.
  • Process Development : Design and implement scalable processes and systems for the creation of patient-specific products, ensuring compliance with FDA and ISO standards.
  • 3D Modeling : Develop complex 3D models, drawings and reports using commercial, research and proprietary software for use within production processes.
  • Documentation : Draft detailed documentation to support process development projects and production processes.
  • Product Definition : Understand the product design specifications, goals and objectives to develop and refine Digital Production processes and systems.
  • Process Optimization : Evaluate and refine existing design procedures, implementing best practices to enhance workflow and reduce cycle times.
  • System Integration : Create / update Digital Production processes and systems that integrate into overall business processes and other manufacturing systems.
  • Software Projects : Participate in Digital Automation projects to develop / release new or updated software packages for use within the Digital Production systems.
  • Training : Train technical production staff, among others, fostering a culture of continuous learning and improvement.
  • Testing : Prepare, coordinate and execute various scopes of testing relative to projects.
  • Production Release : Prepare, coordinate and support production releases.
  • Problem Solving : Collaborate with Production, Product Development and Digital Automation teams, among others, to troubleshoot complex issues related to design and manufacturing processes.
  • Product Development : Participate in Product Development projects to innovate new processes and technologies that can enhance product offerings and operational efficiency.
  • Quality Assurance : Lead quality improvement initiatives and ensure adherence to quality management systems. Conduct regular audits and evaluations of existing processes to enhance accuracy and efficiency. Perform investigations and reporting as needed.
  • Other Duties : Perform all other duties or responsibilities as assigned.

Qualifications and experience

Required Skills :

  • Excellent written and verbal communication skills.
  • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
  • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
  • Strong organizational, analytical, and time-management skills.
  • Self-motivated with the ability to work independently and collaboratively.
  • Interpersonal skills (verbal and written) sufficient for effective interaction with customers and colleagues.
  • Willingness to work flexible hours as needed.
  • Ability to adapt to changing conditions within the department, managing frequent interruptions.
  • Must demonstrate flexibility and willingness to adapt to diverse roles as a member of the corporate team.
  • Must be aware of hazards within the company; adhere to safety standards established by FDA and other regulatory agencies (large magnetic field, ionizing radiation, universal precautions, etc.).
  • Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, etc.).
  • Willingness to learn needed skills on the job in order to enhance performance.
  • Understanding of various development, production and quality processes.
  • Be proactive and anticipate tasks required to complete assignments.

    • Education and Experience :

  • Minimum of 2-3 years’ experience using 3D CAD modeling software.
  • Experience with developing and implementing production processes.
  • Experience with software testing.
  • Experience in a regulated field, medical device field is a plus.
  • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or equivalent Engineering

    • Physical Requirements :

  • Prolonged periods sitting at a desk and working on a computer.
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