Seeking a seasoned Process Development Engineer to lead the development of cutting-edge medical devices and drive innovation in the industry.
Job Description
The successful candidate will be responsible for leading Process Development and Manufacturing Engineering activities, working closely with suppliers and cross-functional teams to ensure seamless transitions and compliance with regulatory standards.
* Lead the development and implementation of manufacturing capabilities using LEAN principles and tools, including Value Stream Mapping, Poka-Yoke, Standard Work, Bottleneck Analysis, and Line Balance.
* Work with Quality to manage Non-Conforming Material Reports (NCMRs) and Corrective Action Preventive Actions (CAPAs), supplier monitoring, audits, risk management, and internal controls, ensuring compliance with ISO 13485 and other relevant standards.
* Develop and execute commercial manufacturing timelines consistent with project and regulatory needs, providing technical leadership for company's long-term manufacturing and distribution channels.
Required Skills and Qualifications
To succeed in this role, you will need:
* A Bachelor's degree in engineering or a related field, with a minimum of 7 years' experience, including at least 3 years in a technical leadership role in a biotechnology, pharmaceutical, or medical device industry.
* Experience working within ISO 13485/FDA regulated quality systems, with a strong understanding of risk management methodology.
* A proven track record in manufacturing and process development in a regulated environment, with experience in managing budgets and leading cross-functional teams.
Benefits
This is an excellent opportunity to work in a fast-paced, high-growth environment, with a competitive salary and benefits package. The successful candidate will have the opportunity to develop their skills and expertise, working with a talented team of professionals.