We have a current opportunity for a Process Development Engineer on a contract basis. if you are interested or know anyone that is then please contact me further.
Key Responsibilities:
- Support R&D activities during the product design phase.
- Manage process introductions while mitigating product and process risks, increasing yields, and improving efficiency.
- Work with vendors to develop and validate an automated system for production.
- Oversee the introduction of designed equipment into a production environment.
- Lead the process introduction through validation efforts, ensuring all stakeholder needs are met and all involved departments complete their tasks on time.
- Plan the process introduction, focusing on budget and timelines, while ensuring product quality is not compromised.
- Apply innovative problem-solving methods to address process, safety, product, timeline, and budget risks.
- Identify and implement new technologies to support chemical processes where applicable.
Qualifications:
- Bachelor's degree or higher in Mechanical or a related Engineering field.
- At least 5 years of proven experience in the medical device industry.
- Previous experience in high-volume equipment development is helpful but not required.
- Experience in developing processes through risk and validation streams.
- Strong knowledge in validation, risk management, change management, statistical analysis, and process characterisation.
- Familiarity with ISO requirements, GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes.
- Experience in participating in multi-functional teams and facilitating NPD (New Product Development) design transfer to manufacturing.
