Engineer II, Device Quality

BioCT; Danbury (CT); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality systems

Risk management

Regulatory knowledge

Cross-functional collaboration

Formation

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

Outils

Microsoft Office

Description du poste

MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.

Job Summary

The Device Quality and Risk Management Engineer will be responsible for supporting medical device quality and risk management activities for existing and new products throughout the product lifecycle. This role assists with design controls, risk management, quality system compliance, investigations, CAPA, supplier quality, and regulatory inspections under the guidance of senior quality and risk management personnel. The position works collaboratively with cross-functional teams to support risk-based decision making and help ensure device products comply with FDA QMSR, ISO 13485, EU MDR, and internal quality system requirements.

Essential Duties

• Support medical device quality system activities, including the development and maintenance of Design and Development Files, to ensure compliance with applicable regulatory requirements and standards, including FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, and internal Quality Management System procedures.
• Assist with quality review of design and development plans, deliverables, and associated documentation throughout the product lifecycle.
• Support quality activities related to device manufacturing, assembly, testing, packaging, labeling, and component suppliers to help ensure product conformity, regulatory compliance, and continuity of supply. Review and contribute to quality documentation, including procedures, protocols, reports, batch records, and technical files, to support accuracy and inspection readiness.
• Participate in risk management activities throughout the product lifecycle, including the development, review, and maintenance of risk management documentation, to support effective identification, evaluation, control, and monitoring of risks impacting product quality, regulatory compliance, patient safety, and business operations.
• Assist cross-functional teams in applying risk management methodologies such as FMEA, FTA, HAZOP, and Hazard Analysis, and support updates to risk assessments resulting from new information, process changes, investigations, or regulatory requirements.
• Support risk assessments associated with deviations, CAPAs, complaints, nonconformances, and OOS investigations. Escalate quality and compliance concerns to management as appropriate.
• Participate in internal audits, supplier audits, and regulatory inspections by assisting with documentation, risk management records, responses, and follow-up activities.
• Support continuous improvement initiatives through the collection, analysis, and reporting of quality and risk management data and metrics.
• Observe all Company Health, Safety, and Environmental guidelines.
• As a member of the Quality organization at MannKind Corp. the incumbent is also expected to use quantitative reasoning; and to be professional, committed to excellence, customer focused, detail oriented, a communicator, and a team player.
• Demonstrate self-motivation and initiative by independently expanding technical knowledge and seeking opportunities to improve the effectiveness of device quality and risk management activities.
• Maintain awareness of evolving regulatory requirements, industry standards, guidance documents, and best practices through routine review of applicable regulations, standards, scientific literature, and industry publications.
• Apply knowledge gained through research, professional development, and industry benchmarking to support continuous improvement, regulatory compliance, risk-based decision-making, and operational excellence.

Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.

Minimum Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or a 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 Quality System Regulation (21 CFR Part 820/QMSR), ISO 13485, ISO 14971, EU MDR, and related regulatory requirements.
• Familiarity with risk management methodologies, including Failure Modes and Effects Analysis (FMEA), Hazard Analysis, Fault Tree Analysis (FTA), or similar risk assessment tools.
• Experience supporting quality system processes such as investigations, CAPA, change control, validation, supplier quality, document control, or design controls.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
• Strong written and verbal communication skills with the ability to effectively collaborate across cross-functional teams.
• Strong analytical, problem-solving, technical writing, and organizational skills.
• Ability to manage multiple priorities and work effectively in a fast-paced, regulated environment.
• Demonstrated initiative and self-motivation with the ability to work independently while seeking guidance when appropriate.
• Commitment to continuous professional development through ongoing review of applicable regulations, standards, guidance documents, scientific literature, and industry best practices.
• Ability to research, interpret, and apply regulatory requirements, industry standards, and emerging best practices to support compliant and effective quality and risk management activities.