Principal Post-Market Quality Engineer

Medtronic plc; Minneapolis (MN); Presencial; USD 121.000 - 181.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, Dental and Vision insurance

401(k) plan with company match

Tuition assistance

Descripción de la vacante

Medtronic Neuroscience is seeking a Principal Quality Engineer to lead Post Market Quality activities for Neuromodulation and Pelvic Health, driving investigations, CAPAs, risk assessment, and quality-system improvements to maintain safety and effectiveness of therapies.

You will partner with cross‑functional teams, mentor engineers, and ensure compliance with FDA QSR and ISO 13485, while working onsite four days a week in the U.S. and contributing to service depot operations.

Formación

• Bachelor's degree (or advanced degree) with 7+ (5+) years in Quality/Med device sectors.
• Experience leading investigations into product quality issues and customer complaints.
• Experience with CAPA processes and quality system requirements.
• Knowledge of quality risk assessment methods and regulated quality systems.
• Experience in a regulated industry environment.

Responsabilidades

• Lead Post Market Quality activities for Neuromodulation and Pelvic Health Service Depot operations.
• Drive investigations, root-cause analysis, and CAPA implementation.
• Evaluate post-market data and risk signals to support decision-making and product performance.
• Develop and present Product Performance Reviews using trend analysis and quality metrics.
• Collaborate with cross-functional teams to ensure quality system compliance and continuous improvement.

Conocimientos

CAPA processes

Investigations

Quality system

Regulatory knowledge

Quality leadership

Educación

Bachelor's degree

Advanced degree

Descripción del empleo

Medtronic Neuroscience is seeking a Principal Quality Engineer to lead Post Market Quality activities for Neuromodulation and Pelvic Health, driving investigations, CAPAs, risk assessment, and quality-system improvements to maintain safety and effectiveness of therapies.

You will partner with cross‑functional teams, mentor engineers, and ensure compliance with FDA QSR and ISO 13485, while working onsite four days a week in the U.S. and contributing to service depot operations.