Director Systems Integration and Validation

The Respiratory Group of Tyco Healthcare consists of Nellcor and Puritan Bennett (NPB). Nellcor's pulse oximetry and critical care solutions are used every day in healthcare environments worldwide. Puritan Bennett has been a leading innovator of mechanical ventilation and respiratory care devices for over 50 years. NPB has a future vision to excel in non-invasive monitoring of new vital parameters, complete solutions to sustain critical patients with respiratory impairment, and enhance practical solutions for home diagnosis and management of chronic diseases. We are in the process of moving our NPB headquarters to beautiful Boulder, Colorado. For more information, please visit www.tycohealthcare.com

SUMMARY OF POSITION:
Responsible for ensuring that system verification and validation testing of medical devices consisting of software and / or hardware produce the safety, quality and reliability stipulated in the product requirements document. These tests must also comply with regulatory authorities, and notified bodies (e.g. FDA Design Controls, QSRs and TUV).

Via subordinate supervisors and mangers oversee and manage test engineers in their support of V&V testing across multiple product lines. Understand current hardware and software industry standards and practices and FDA regulations and their impact on internal procedures, safety and efficacy. Ability to interact with FDA inspectors and auditing body agencies during audits. Provide management and technical leadership within R&D to effectively drive development activities in support of the division’s goals. Establish and monitor department goals and objectives and ensures they are being met on time and within budget constraints. On an ongoing basis provide higher management with reports on project progress and costing.

MINIMUM QUALIFICATIONS:

Education:
Bachelor of Science degree in Electronics Engineering, Mechanical Engineering, Computer Science, or Computer Engineering. MS or MBA degree preferred.

Experience:
8+ years of management role in software / hardware product testing and/or quality/reliability design engineering . Experience gained by managing multiple departments within and/or across functions.

Preferred Skills/Qualifications:
Medical Device industry or aerospace quality assurance experience in developing, recommending, implementing and administering quality policy is preferred.

Skills/Competencies:
Creative problem solver, ability to prioritize according to risk needs

Other Skills:
Excellent written and verbal communication skills

Understand current software /hardware quality techniques, industry standards (e.g. ISO, IEEE, CMM), and FDA Quality System Regulations and their impact on internal procedures, safety and efficacy of products. Must possess knowledge and experience in product risk analysis, requirements management and tracing, defect tracking, and configuration management when they are used in the development lifecycle.
Possess knowledge and experience with national and international QA testing standards & techniques such as product risk assessment ISO 14971 requirements management and tracing, configuration management, and how they are applied in the software / hardware development lifecycle
Support QA during FDA or any regulatory agency audits.
Manage department resource allocation across multiple business needs
Able to most effectively use inside or outside resources to achieve goals and objectives of GBU
Provide employee development and advancement opportunities for department staff
Effective hiring, coaching and mentoring skills
Assure staff compliance with all safety and training requirements and certifications
Ability to drive change, demonstrate effective decision making, and provide direction for quality operations
Strong written and verbal communication skills

How to apply:
To apply go to: www.tycohealthcarecareers.com. Pull up jobs for Boulder, Colorado. Respiratory jobs are located under Nellcor/Puritan/Bennett.

Please apply online.