Job Title: Process Development Engineer
The primary focus of this role is to develop and execute test method validations for equipment in accordance with current quality management system and regulatory standards.
* Develop and implement medical device manufacturing processes as assigned, ensuring adherence to established guidelines and protocols.
* Identify equipment/fixture installation qualification requirements, collaborating with cross-functional teams to ensure seamless integration.
* Characterize processes and their outputs/acceptance criteria, utilizing statistical analysis and data-driven decision making to drive improvement.
* Prepare comprehensive validation reports that meet regulatory and company standards, showcasing expertise in technical writing and documentation.
Maintain accurate and timely records, ensuring compliance with regulatory requirements. Foster strong working relationships with colleagues, promoting a collaborative environment.
Prior experience in a related field is essential, with relevant certifications or education preferred. A bachelor's degree in engineering or a related field is highly desirable.