Job Title:
Principal Process Development Engineer
Company Overview:
Our client, a medical device start-up, is developing cutting-edge innovative devices to significantly advance healthcare.
Key Responsibilities:
* Technical leadership of the manufacturing transfer of new products and changes to existing products, supporting the successful transition to manufacturing using design for manufacturability concepts, as applicable.
* Develop and Implement manufacturing capabilities using LEAN principles and tools including but not limited to Value Stream Mapping, Poka-Yoke, Standard Work, Bottleneck Analysis and Line Balance.
* Responsible for working with Quality including management of NCMRs and CAPAs, supplier monitoring and audits, risk management and internal controls while ensuring compliance with ISO 13485 and other relevant standards and regulations pertaining to medical device and pharmaceutical products.
Requirements:
* Bachelor's degree in engineering or related specialty with a minimum of 7 years experience with at least 3 years in a technical leadership role in a biotechnology, pharmaceutical or medical device industry.
* Experienced in working within ISO 13485/FDA regulated quality systems with understanding and application of risk management methodology.
* A proven track record in manufacturing and process development in a regulated environment.
Skills:
* Process Development
* NPI Development Engineer
What We Offer:
A dynamic and innovative work environment with opportunities for growth and development. A chance to work on cutting-edge projects and make a real impact in the field of medical devices.