Sr Software Design Quality Engineer at Covidien in Boulder CO

General Information:

Job Description

Design and deliver the medical device and supplies breakthroughs that make a difference in the lives of millions of patients.
The Senior Software Design Quality Engineerensures that software used in the development, manufacturing and as part of medical devices 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 forsoftware design quality. Mentor design teams on quality systems and requirements.

What is the work you will be doing?

Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report
Promote a structured software development process. Assure that control is maintained for in-house and outsourced software development.
Ensure compliance with internal and external procedures and regulations.
Participate in review of requirements, architecture, design, code and other work products with a focus on patient safety and device quality, testability, manufacturability and serviceability.

Required: experiences or skills

5+ years of software design quality / compliance engineering experience or equivalent
Working knowledge of C++, the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and knowledge of how these are applied in the software development lifecycle
Understanding of current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products

Preferred: experiences or skills

Understanding of Object Oriented programming techniques
Working knowledge of Unified Model Language (UML)
ASQ CQE, CRE or CSQE certification
Strong familiarity with regulatory requirements (e.g. ISO 62304, ISO 13485, 21 CFR Part 11, 21 CFR 820, ISO 14971).
Experience in risk evaluation techniques, such as PRA (Product Risk Assessment), FMEA & fault tree analysis.
Familiar with reliability analysis and test methods, including HALT and HASS.

For more information and to apply contact Galit Dana, Lead Sourcing Specialist at Covidien

or visit Covidien Job ID Number: 140003KA web page