Engineer II, Device Quality

MannKind Corporation•Danbury, CT

About The Position

The Device Quality and Risk Management Engineer supports medical device quality and risk management activities for existing and new products throughout the product lifecycle. Under the guidance of senior quality and risk management personnel, this role assists with design controls, risk management, quality system compliance, investigations, CAPA, supplier quality, and regulatory inspections. The position works 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. The role supports development and maintenance of Design and Development Files; reviews design plans, deliverables, and documentation; and contributes to quality activities across manufacturing, assembly, testing, packaging, labeling, and component suppliers. It also supports risk management records and assessments, audits and inspections, quality data analysis, and continuous improvement. The incumbent is expected to maintain awareness of evolving regulations and industry practices, apply research and professional development to quality activities, and observe Company Health, Safety, and Environmental guidelines. Other assignments may be included as necessary.

Requirements

Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.
At least 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 FMEA, Hazard 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 and ability to 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.
Initiative and self-motivation, with the ability to work independently while seeking guidance when appropriate.
Commitment to ongoing professional development through 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.

Responsibilities

Support medical device quality system activities, including developing and maintaining Design and Development Files in accordance with applicable regulations, standards, and internal 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.
Review and contribute to procedures, protocols, reports, batch records, and technical files to support accuracy and inspection readiness.
Participate in lifecycle risk management activities, including developing, reviewing, and maintaining risk management documentation.
Assist cross-functional teams in applying FMEA, FTA, HAZOP, and Hazard Analysis, and support risk assessment updates prompted by 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, including documentation support, risk management records, responses, and follow-up activities.
Support continuous improvement initiatives through collection, analysis, and reporting of quality and risk management data and metrics.
Observe Company Health, Safety, and Environmental guidelines.
Maintain awareness of evolving regulatory requirements, industry standards, guidance documents, best practices, scientific literature, and industry publications.
Apply research, professional development, and industry benchmarking to support continuous improvement, regulatory compliance, risk-based decision-making, and operational excellence.
Use quantitative reasoning and demonstrate professionalism, commitment to excellence, customer focus, attention to detail, communication, teamwork, initiative, and self-motivation.