Posted on Sunday, October 14, 2007
Various Jobs - Covedian

The Respiratory and Monitoring Solutions Group of Covidien, formerly Tyco Healthcare is currently recruiting for the following positions:

SOFTWARE QUALITY ENGINEERING MANAGER – Boulder, CO

Position Summary:
Oversee and manage Software Quality Assurance Engineers ensuring that software used in the development, manufacturing, and as part of medical devices is developed according to good design practices as set forth by regulatory authorities (e.g. FDA/TUV).

Minimum Requirements:

• BS degree in Electrical Engineering, Computer Science, or Computer Engineering
• 6+ years exp in software test or software quality engineering with embedded software as part of a medical device
• Experience in a management role
• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, & 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
• 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
• Working knowledge of C, C++
• CSQE Certification

SR. SOFTWARE QUALITY ENGINEER – 1 position Boulder, CO & 1 position Carlsbad, CA

Position Summary:
Ensuring 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 for computerized system validation.

Minimum Requirements:

• BS in Electrical Engineering, Computer Science, or Computer Engineering
• 5+ 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, 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, IEEE, CMMI), and FDA Quality System
• Regulations and their impact on internal procedures, software quality, safety and efficacy of products
• Working knowledge of C, C++, and LabVIEW

REGULATORY AFFAIRS SPECIALIST – Boulder, CO

Position Summary:
Ensures compliance to FDA and other applicable regulations. Prepares, analyzes, and submits dossiers to various governing agencies in supporting business growths. Supports applicable regulations including ISO, local, state, and/or federal requirements.

Minimum Requirements:

• 5-8 years of RA experience
• B.S. or B.A. degree required.
• Must have knowledge of U.S. and/or European/International regulations and standards
• Experience in preparing regulatory submissions
• Experience interacting with FDA and/or other regulatory agencies

COMPLIANCE OFFICER – Boulder, CO

Position Summary:
Develops, establishes and maintains quality assurance and regulatory programs, policies, processes, procedures and controls to ensure that the performance and quality of products conform to established standards and agency guidelines.

Minimum Requirements:

BS/BA degree or equivalent experience with 3-7 years medical device.

• 2 years auditing experience; hands on experience managing and/or supporting FDA and Notified Body inspection/audits.
• Comprehensive knowledge of FDA Quality System Regulation, ISO, Medical Device Directive, Canadian Medical Device Regulation, and other international requirements.
• Knowledge of all Quality System elements, including Complaint Handling, CAPA, Design Control, Validation Review
• ASQ Certified Quality Auditor and Lead Auditor training are highly desired.

For more information about these and other opportunities go to: www.covidien.com/careers. Pull up jobs for Boulder, CO. Respiratory jobs are listed under Nellcor/Puritan/Bennett.
Recruiter Contact Information: Deborah.Cason@covidien.com