Principal Quality Engineer

What you'll do

• Lead Health Risk Assessments to determine potential risks and recommend necessary Field Corrective Actions.
• Monitor product performance in the field by collecting and analyzing reliability data to identify trends.
• Lead root cause investigations into product failures and complaints using established analysis techniques.
• Manage complaint trending and investigate quality signals or excursions from the field.
• Assess design impacts of changes and approve FMEAs, test validations, and verification reports.
• Implement design, process, or supplier changes to improve product reliability and performance.
• Provide technical support to customers and field personnel regarding reliability issues and product performance.
• Provide technical mentorship and coaching to junior engineers within the organization.

What we're looking for

• A Baccalaureate degree in STEM or a related technical discipline with at least 7 years of relevant experience is required.
• A Master's degree with at least 5 years of relevant experience is required.
• A PhD with at least 3 years of relevant experience is required.
• Experience in the medical device industry across product development, operations, or quality functions (preferred).
• Demonstrated expertise in risk management in accordance with ISO 14971 (preferred).
• Strong technical writing and communication skills to explain complex topics to non-technical audiences (preferred).
• Proven ability to lead root cause investigations, solve complex technical problems, and perform statistical data analysis (preferred).
• Work authorization at the time of hire and for the duration of employment.