Senior Manufacturing Process Engineer
We are seeking a Senior Manufacturing Process Engineer to support our 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 areas 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 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:
* Bachelor's, Master's or PhD degree in Science, Mechanical Engineering, Manufacturing, Chemical Engineering, Biomedical Engineering, or other 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.
* An excellent knowledge of engineering materials used in medical devices.
* A strong problem solver with knowledge and experience of DMAIC or other problem-solving tools.
* Must be organized, 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 in English.
* Comfortable with hands-on and technical work.