
Senior Plastics Process Innovation Specialist
3 days ago
We are seeking a skilled NPI Plastics Process Engineer to join our team.
This is an exciting opportunity for an experienced engineer to lead the introduction of new mould tooling, oversee First Off Tests (FOTs), Functional Assembly Tests (FATs), and process transfer to production.
Key Responsibilities:- Tool Development Lead: Oversee the design and development of new mould tooling, ensuring seamless integration with existing processes.
- Process Optimisation: Develop and optimize Scientific Injection Molding (SIM) processes to improve efficiency and quality.
- Troubleshooting: Troubleshoot molding and assembly issues during production runs, utilizing expertise to resolve complex problems.
- Documentation: Document and validate new product processes and tooling changes, maintaining accurate records.
- Mentorship: Mentor technicians and operations teams in SIM and process control, sharing knowledge and best practices.
- Compliance: Ensure compliance with ISO13485, cGMP, and safety standards, maintaining regulatory requirements.
- Travel: Travel to toolmakers, customer sites, and vendors as needed (10–50%), representing the company professionally.
- Bachelor's Degree: Hold a Bachelor's degree in engineering (Mechanical, Manufacturing, Polymer, or related).
- Certifications: Additional certifications in Scientific Injection Molding (SIM), RJG, or Lean Six Sigma are highly desirable.
- Experience: Requires extensive experience in plastics manufacturing, ideally within medical devices, pharma, or regulated environments.
- New Product Introduction: Proven track record in New Product Introduction (NPI), especially involving mould tool development and validation.
- Regulatory Knowledge: Experience working with ISO13485, cGMP, and FDA-regulated processes.
- Injection Moulding: Deep knowledge of injection molding, tooling, and polymer materials.
- Hands-on Experience: Hands-on experience with FOTs, FATs, and process transfer to production.
- Design of Experiments: Skilled in Design of Experiments (DOE), process validation, and troubleshooting.
- Communication: Strong communicator and technical mentor for operations staff, comfortable with travel (10–50%).
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