Process Engineer I

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

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