Job Description
Our client, a medical device start-up developing cutting-edge innovative devices to significantly advance healthcare, is seeking a Principal Process Development Engineer.
Key Responsibilities:
* Technical leadership of manufacturing transfer for new products and changes to existing products, supporting 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.
* Work with Quality, managing 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 devices and pharmaceutical products.
Requirements:
* Bachelor's degree in engineering or related specialty with at least 7 years' experience, including 3 years in a technical leadership role in biotechnology, pharmaceutical, or medical device industry.
* Experience working within ISO 13485/FDA regulated quality systems, with understanding and application of risk management methodology.
* Proven track record in manufacturing and process development in a regulated environment.
Preferred Skills:
* Medical device catheter product experience.
* Ability to achieve results in a virtual organisation.
* Experience working with cross-functional teams, project facilitation, and demonstrated ability to complete projects on time.
* Knowledge and skills in DFM, technology evaluation, driving innovative solutions to complex problems, process design and development, materials (polymers and metals), design for six sigma principles, CAD (SolidWorks preferred), statistical techniques, process validation and control along with Manufacturing KPIs.