Device Quality & Risk Engineer — MedTech (Regulated)

MannKind Corporation; Danbury (CT); On-site; USD 90,000 - 130,000; Full time

Job summary

MannKind Corporation is seeking a Device Quality and Risk Management Engineer to support quality system activities across the product lifecycle, ensuring compliance with FDA QMSR, ISO 13485, EU MDR, and internal procedures. You will work with cross-functional teams to manage risk assessments and design controls, contributing to CAPA, investigations, and supplier quality.

The role requires a Bachelor’s degree in a technical field and a minimum of three years’ regulated manufacturing experience.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline.
• Minimum of three (3) years of experience in medical device, combination product, pharmaceutical, or other regulated manufacturing environments.
• Working knowledge of FDA QSR (21 CFR Part 820)/QMSR, ISO 13485, ISO 14971, EU MDR, and related regulatory requirements.
• Familiarity with risk management methodologies (FMEA, Hazard Analysis, FTA) or similar tools.
• Experience supporting quality system processes: investigations, CAPA, change control, validation, supplier quality, document control, or design controls.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
• Strong written and verbal communication skills and collaboration across teams.
• Ability to manage multiple priorities in a fast-paced, regulated environment.
• Demonstrated initiative and self-motivation; continuous professional development.

Responsibilities

• Support medical device quality system activities across product lifecycle.
• Contribute to design controls, risk management, investigations, CAPA, and regulatory inspections.
• Assist with supplier quality, manufacturing quality, labeling, and change control.
• Develop and maintain risk management documentation (FMEA, risk assessments).
• Escalate quality and compliance concerns as appropriate.
• Participate in internal/audits, supplier audits, and regulatory inspections.
• Support collection, analysis, and reporting of quality and risk data for improvements.

Skills

Quality systems

Risk management

Regulatory knowledge

Communication

Analytical thinking

Education

Bachelor's degree in Engineering/Life Sciences/Quality

Tools

MS Office

Document control software

Job description

MannKind Corporation is seeking a Device Quality and Risk Management Engineer to support quality system activities across the product lifecycle, ensuring compliance with FDA QMSR, ISO 13485, EU MDR, and internal procedures. You will work with cross-functional teams to manage risk assessments and design controls, contributing to CAPA, investigations, and supplier quality.

The role requires a Bachelor’s degree in a technical field and a minimum of three years’ regulated manufacturing experience.