My client who are a growing Medical Device start-up company are seeking a Senior manufacturing Process engineer to support their operations team as they ramp up through pilot production to commercial launch.
Responsibilities

• Provide day to day support to the line technician and product builders, in terms of troubleshooting equipment and process related issues. Provide training to line technicians.
• Manage the manufacturing process, understand the process risks and identify mitigations leading to improving yields and process efficiency.
• Work with equipment vendors to identify area for process improvement.
• Create a strong culture of problem solving using standard tools like DMAIC and 6 sigma.
• Create and follow a process development plan for the line equipment.
• Responsible for all line equipment in terms of equipment, ensuring maintenance and calibration is up to date.
• Execution of IQ/OQs for lab and production equipment.
• Communicate and update project activities using project management methodologies.

Background & Qualifications

• Bachelors, Masters or PhD degree in Science, Mechanical Engineering, Manufacturing, Chemical Engineering Biomedical Engineering or other relevant engineering discipline.
• At least 5 years work experience in a manufacturing or process development related role in a medical device company.
• Demonstrated experience with GDP & GMP standards.
• Have an excellent knowledge of engineering materials used in medical device
• A strong problem solver with knowledge and experience of DMAIC or other problem-solving tools.
• Must be organised, demonstrate innovation and have a strong work ethic on individual projects and as part of a project team.
• Effective communication skills. Both verbal and written - English
• Extremely comfortable with hands-on and technical work

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