Our company, a rapidly growing Medical Device start-up, is seeking a highly skilled Senior Manufacturing Process Engineer to support our operations team as we scale through pilot production to commercial launch.
Key Responsibilities
* Provide daily support to line technicians and product builders in troubleshooting equipment and process-related issues.
* Deliver training to line technicians to enhance their skills.
* Oversee the manufacturing process, identify potential risks, and implement mitigations to improve yields and process efficiency.
* Collaborate with equipment vendors to identify areas for process improvement.
* Create a culture of problem-solving using standardized tools like DMAIC and Six Sigma.
Process Development
Develop and execute a comprehensive process development plan for line equipment, ensuring maintenance and calibration are up-to-date.
Equipment Management
Responsibly manage all line equipment, including ensuring maintenance and calibration are current.
Project Management
Execute IQ/OQs for lab and production equipment, communicating project activities using project management methodologies.
Requirements
* Bachelor's, Master's, or Ph.D. degree in Science, Mechanical Engineering, Manufacturing, Chemical Engineering, Biomedical Engineering, or a relevant engineering discipline.
* At least 5 years of work experience in a manufacturing or process development-related role in a medical device company.
* Demonstrated experience with GDP & GMP standards.
* Excellent knowledge of engineering materials used in medical devices.
* Strong problem-solving skills, including knowledge and experience with DMAIC or other problem-solving tools.
* Organized, innovative, and dedicated to individual projects and team collaboration.
* Effective communication skills (verbal and written) in English.
Proficiency in hands-on and technical work.