Process Development Engineer

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.