Job Overview:
This role supports the operations team in manufacturing New Product Introduction (NPI) activities. We are looking for a professional who can execute equipment, process and test method validations, support the manufacturing process, understand risks and identify mitigations to improve yields and efficiency.
To achieve this, you will track and execute NPI activities ahead of commercialization, work with vendors to identify process improvement areas and create a problem-solving culture using DMAIC and 6 sigma methodologies.
* Execute equipment, process and test method validations.
* Support the manufacturing process, understand risks and identify mitigations to improve yields and efficiency.
* Track and execute NPI activities ahead of commercialization.
* Work with vendors to identify process improvement areas.
* Create a problem-solving culture using DMAIC and 6 sigma.
* Develop a process development plan focusing on risk and timeline.
* Collaborate with R&D to ensure production plans align with their programs.
* Update master validation plans for line equipment.
* Ensure maintenance and calibration are up-to-date for all line equipment.
* Execute IQ/OQs for lab and production equipment.
Requirements:
* Bachelor's degree in Mechanical Engineering, Manufacturing, Chemical Engineering, Biomedical Engineering or relevant discipline.
* At least 2 years' experience in a manufacturing or process development role in a medical device company.
* Experience with new equipment introduction, process characterization and validation.
* Knowledge of engineering materials including hydrogels, metals and polymers.
* Excellent problem-solving skills, including experience with DMAIC or other tools.
* Strong organizational skills, innovation and work ethic.
* Effective communication skills, both verbal and written.