As a Senior Quality Engineer within Medtronic’s Surgical Innovations business, you will have responsibility for providing Quality Engineering support as a member of the cross-functional team responsible for quality compliance and risk management in accordance with EN ISO 14971. You will support the Quality System, analyzing customer complaints, conducting risk management reviews and updates to ensure quality considerations are adequately covered in the design, testing, and release of products and take actions to correct deficiencies.
- Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
- Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
- Ensures that corrective measures meet acceptable reliability standards.
- Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
- Completes risk analysis studies of new design and processes.
- Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
- May develop mathematical models to identify units, batches or processes posing excessive failure risks.
- As necessary, proposes changes in design or formulation to improve system and/or process reliability.
- Able to work independently
- Strong communication skills
- Working knowledge of EN ISO 14971
- Working Knowledge of ISO 13485
- Bachelor’s Degree in Engineering or Science field with 4+ years of experience in Quality and/or Engineering
- Master’s Degree in Engineering or Science field with 2+ years of experience in Quality and/or Engineering.
Vacancy Type: Full Time
Job Location: New Haven, CT, US
Application Deadline: N/A