As part of a multidisciplinary process development engineering team the Process Development Engineer will be responsible for engineering support in the definition, design, process development, and production transfer of a wide variety of medical devices. This role includes collaborating with internal engineers, operations, and key client stakeholders.

DUTIES AND RESPONSIBILITIES:

• Identify technologies that meet the manufacturing needs of new product development programs
• Define design criteria and author associated documentation including User Requirements Specifications and Equipment Specifications for highly automated equipment
• Oversee vendor design and fabrication of automated manufacturing equipment
• Lead the definition and execution of the Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ) and process characterization.
• Represent the organization as a primary technical contact for specific projects and initiatives with vendors; communicates with internal and external customers and suppliers at various levels
• Lead efforts for production release of finished goods and components. This includes BOM’s/routings and other ERP required information.
• Develop solutions to complex problems, and/or makes moderate to significant improvements of processes, systems or product independently to enhance performance of the area
• Manage major/complex projects, involving delegation of work and review of work products, at times acting as a team leader
• Make use of appropriate quality tools, such as DOE, SPC, hypothesis testing, and capability studies; to measure, monitor, improve and control the mfg line and select processes
• Identify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes
• Utilize project mgmt skills to drive process development, vendor adherence to program schedules, and validation projects to completion; on time and on budget
• Create written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.g. qualifications, risk assessments, and work instructions)
• Work with product development engineering to drive back lessons learned as new products are being developed
• Provide training and certification for trainers as required
• Lead efforts to investigate and develop new technology related to combination products