Nellcor Puritan Bennett, is now the Respiratory and Monitoring Solutions (RMS) business unit of Covidien, formerly Tyco Healthcare. RMS systems are used to monitor, diagnose and treat respiratory disease and sleep disorders, and they provide life sustaining ventilation and oxygen support for patients.

In addition to Respiratory and Monitoring Solutions, Covidien also manufactures, distributes and services a diverse range of industry-leading product lines, including surgical devices, energy-based devices, pharmaceutical products, imaging solutions, patient care and safety products, and medical supplies.

For more information, visit us as www.covidien.com.

Sr. Software Quality Engineer - Job Summary:

Responsible for ensuring that software used in the development, manufacturing, and as part of medical devices (primarily ventilators and ventilation accessories) is developed according to good design practices and follows the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies. Provide leadership, oversight and training to division manufacturing plants for computerized system validation. Translate standards into processes and procedures and apply these to the design process.

ESSENTIAL FUNCTIONS:
1. Promote a structured software development process. Assure that a state of control is maintained for in-house and outsourced software development.
2. Participate in critical analysis, design, and change review meetings for product and non-product software.
3. Provide oversight of manufacturing software validation process.
4. Generate metrics for assessing software quality and evaluate results.
5. Contribute to process improvements by developing and/or updating written company or departmental procedures related to software development.
6. Administer configuration control system for device, manufacturing and product development tools software. Provide oversight during software release to manufacturing as well as internal distribution.
7. Administer, and control problem-tracking database, and oversee defect process resolution.
8. Support outsourced software vendor audits and qualification.
9. Provide software validation, design controls, and risk management training.

MINIMUM REQUIREMENTS:
Minimum Requirements:
* Bachelor of Science degree in Electrical Engineering, Computer Science, or Computer Engineering
* 7+ years in software quality engineering role dealing with embedded software that is part of a medical device.
* Working knowledge of the FDA Quality System Regulation, ISO 13485, Medical Device Software - Software life cycle processes, IEC 62304 and the Medical Device Directive
* Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle
* Understand current Software Quality techniques, software industry standards (e.g. ISO, IEC, IEEE, CMMI), and FDA General Principles of Software Validation and their impact on internal procedures, software quality, safety and efficacy of products
* Working knowledge of C and C++
* CQE certification - desired

EEO/AA