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.