Device Quality & Risk Management Engineer II

BioCT Innovation Commons; Danbury (CT); On-site; USD 90,000 - 130,000; Full time

Job summary

MannKind Corporation in Danbury, CT is seeking a Device Quality and Risk Management Engineer to support quality systems, design controls, and risk management across the product lifecycle. You will work with cross-functional teams to ensure compliance with FDA QMSR, ISO 13485, EU MDR and internal procedures.

The role emphasizes applying risk methods like FMEA, FTA, and Hazard Analysis, handling investigations, CAPA, supplier quality, and regulatory inspections, while driving continuous

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related discipline.
• Minimum of three years of experience in medical device, combination product, pharmaceutical, or other regulated environments.
• Working knowledge of 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and related regulatory requirements.
• Familiarity with risk management methodologies (FMEA, FTA, HAZOP) or similar tools.
• Experience supporting investigations, CAPA, change control, validation, supplier quality, document control, or design controls.

Responsibilities

• Support design controls and quality system activities across the product lifecycle.
• Assist with risk management documentation and updates.
• Contribute to CAPA, investigations, and nonconformances.
• Support supplier quality, regulatory inspections, and internal audits.
• Collaborate with cross-functional teams to ensure regulatory compliance and patient safety.

Skills

Quality systems

Risk management

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline

Tools

Microsoft Office

Job description

MannKind Corporation in Danbury, CT is seeking a Device Quality and Risk Management Engineer to support quality systems, design controls, and risk management across the product lifecycle. You will work with cross-functional teams to ensure compliance with FDA QMSR, ISO 13485, EU MDR and internal procedures.

The role emphasizes applying risk methods like FMEA, FTA, and Hazard Analysis, handling investigations, CAPA, supplier quality, and regulatory inspections, while driving continuous