Job Description
We are seeking a Principal Process Development Engineer to join our growing team at a medical device start-up, 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 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.
* Contribute to the successful execution of departmental and company goals.
Requirements:
* Bachelor's degree in engineering or related specialty with a minimum of 7 years' experience, 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 understanding and application of risk management methodology.
* A proven track record in manufacturing and process development in a regulated environment.
* Medical device catheter product experience a plus.
Skillset:
* Passion for Engineering concepts and principles.
* Demonstrated ability to drive innovative solutions to complex problems.
* Knowledge and skills in DFM, technology evaluation, CAD (Solid Works preferred), statistical techniques, process validation and control, and Manufacturing KPIs.
* Excellent analytical and decision-making skills.
* Flexible approach to problem-solving, adept negotiator, and risk-based decisions.