Senior Reliability Engineer – Surgical Stapling Systems

BioCT Innovation Commons; North Haven (CT); In loco; USD 107.000 - 161.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Dental insurance

Vision insurance

Health Savings Account

Flexible Spending Account

Life insurance

Long‑term disability

Paid time off

Paid holidays

Employee Stock Purchase Plan

401(k) plan

Well-being programs

Descrizione del lavoro

Medtronic is seeking a Senior Reliability Engineer in North Haven, CT to lead reliability for the CSI Stapling portfolio. You will investigate performance issues, identify failure mechanisms, and guide data-driven decisions across the product lifecycle.

You will work with R&D, Manufacturing, and Supplier Quality to improve product robustness and ensure regulatory compliance, with onsite collaboration most days.

Competenze

• Bachelor's degree with 4+ years of relevant experience OR Master's degree with 2+ years of relevant experience OR PhD.
• Experience in medical device, pharmaceutical, biotechnology, or other regulated product industries.
• Knowledge of ISO 13485, ISO 14971, IEC 60601, and EU MDR is preferred.

Mansioni

• Lead reliability programs including demonstration testing, life testing, and reliability growth.
• Investigate product performance, field quality, and manufacturing issues to identify root causes.
• Apply DOE, regression, confidence intervals, and hypothesis testing to support decisions.
• Partner with R&D to evaluate design changes and support verification, validation, and design reviews.
• Conduct hands-on evaluations, lab investigations, and technical assessments.
• Lead risk management activities including FMEA and maintenance of risk docs.
• Review engineering, supplier, and manufacturing changes for quality and regulatory compliance.
• Analyze complaint and post-market data to identify trends and drive improvements.

Conoscenze

Design controls

Risk management

FMEA

DOE

Statistical analysis

Embedded software

Electromechanical systems

Root cause analysis

AI in engineering

Formazione

Bachelor's degree in a relevant field

Master's degree in a related field

PhD

Strumenti

Minitab

Descrizione del lavoro

Medtronic is seeking a Senior Reliability Engineer in North Haven, CT to lead reliability for the CSI Stapling portfolio. You will investigate performance issues, identify failure mechanisms, and guide data-driven decisions across the product lifecycle.

You will work with R&D, Manufacturing, and Supplier Quality to improve product robustness and ensure regulatory compliance, with onsite collaboration most days.