About the job
Nextern is seeking a skilled and experienced Principal Process Development Engineer to join our dynamic process development engineering team. In this pivotal role, you will provide engineering support for the definition, design, process development, and production transfer of a diverse range of innovative medical devices. Collaborating closely with internal engineers, operational teams, and key client stakeholders, you will play a crucial role in our commitment to excellence.
Key Responsibilities:
- Identify and evaluate technologies that align with the manufacturing requirements of new product development initiatives.
- Establish design criteria and prepare comprehensive documentation, including User Requirements Specifications and Equipment Specifications for highly automated systems.
- Oversee the design and fabrication processes of automated manufacturing equipment by external vendors.
- Lead the planning and execution of Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), and process characterization.
- Act as the primary technical liaison for specific projects, effectively communicating with both internal and external stakeholders.
- Coordinate production release activities for finished goods and components, ensuring all necessary BOMs, routings, and ERP information are accurate.
- Develop solutions for complex engineering challenges and implement significant process improvements independently to enhance operational performance.
- Manage large-scale projects, including delegation and review of team outputs, while occasionally taking on leadership responsibilities.
- Employ quality tools such as DOE, SPC, hypothesis testing, and capability studies to monitor and enhance manufacturing processes.
- Identify opportunities for process improvements and provide technical solutions through hands-on analysis and interaction with designated processes.
- Utilize project management skills to oversee process development, ensure vendor compliance with schedules, and validate projects are completed on time and within budget.
- Create detailed documentation, test plans, and reports that substantiate technical decisions, including qualifications, risk assessments, and work instructions.
- Collaborate with product development engineering to integrate lessons learned into the design of new products.
- Provide training and certification for trainers as required.
- Lead initiatives to explore and develop new technologies related to combination products.
