We are currently searching for a Senior Design Quality Engineer to join an exciting medical device start up in Carlsbad, CA. This rapidly growing company is expected to go public early next year. The Senior Design Quality Engineer will “own” the risk management process and design controls for two key medical device platforms in different development stages.
Requirements of the Senior Design Quality Engineer:
- Bachelor’s degree in engineering or related scientific field.
- 5+ years experience in quality engineering, manufacturing or R&D experience for medical devices.
- Strong working knowledge of ISO 14971
- Demonstrated hands-on experience with design assurance, design controls, design verification and validation, design test method development and design freeze or pre-design freeze feasibility testing.
- Working knowledge of software development life cycle processes in accordance with IEC 62304.
- Experience leading design assurance and development activities such as engineering studies, drawing reviews and feasibility testing for new product development.
- Experience developing quality assurance specifications, inspection procedures, test methods, sampling plans and written procedures.
- Working knowledge of usability engineering processes in accordance with IEC 62366.
Responsibilities of the Senior Design Quality Engineer:
- Lead engineering solutions in regards to quality assurance, design controls and risk management.
- Oversee maintenance of risk management files in accordance with ISO 14971 and other regulations such as FMEAs, hazard analysis, reports and software hazard analysis.
- Oversee test method development and validation activities.
- Lead master validation plans, new product launch, process validations, product verification and validation and design transfer into manufacturing.
- Oversee the continuous improvement of methods and systems to ensure full compliance in manufacturing.
- Ensure production requirements and assembly operations are met through active involvement.
- Prepare documentation for regulatory submissions.
Occupational Category: 17-2141 Mechanical Engineers
: Please apply using the form or send your resume to Debbie Winkelbauer