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

The University of Miami Miller School of Medicine has two new positions for a Healthcare Management Engineer.

Job Description
Define areas that can undergo potential operational improvements. Collect data and provide analysis to assist in the development of technology plans and strategies to enhance overall performance, reduce costs, and increase patient satisfaction. Analyze established operational systems, methods, practices and procedures to evaluate their effectiveness, utilizing advanced management engineering techniques. Study existing information and make recommendations of new processes and procedures for improvements. Integrate people, equipment, facilities and other resources to improve work results, operating efficiency, effectiveness, productivity and/or adaptation to new requirements. Assist in re-engineering efforts using best business practices

Requirements

• Bachelor's degree or equivalent in Industrial or Management Engineering or related fields. Master's degree preferred.
• Six- Sigma Certified preferred.
• Experience on Supply Chain Management is preferred.
• Experience on Operations Research is preferred.
• Demonstrate ability to identify issues and propose methodological solutions, synthesizes analysis well, and highlights implications of findings.
• Demonstrate ability to conduct and interpret quantitative/ qualitative analysis.
• Demonstrate effective communication, consulting, interpersonal, and presentational skills. Any appropriate combination of relevant education, experience and/or certifications will be considered.

Discover all this and countless opportunities that reward your talent. The University of Miami, Miller School of Medicine is proud to offer those who lead with us competitive salaries, medical and dental benefits, tuition remission, vacation, university paid holidays and much more. The University of Miami is an Equal Opportunity/Affirmative Action Employer.

If interested, please apply online at:
https://careers.med.miami.edu/

Libby Montealegre
University of Miami Miller School of Medicine

Responsible for leading the ESI Corporate Quality & Product Assurance team, the Director of Corporate Quality & Product Assurance will be first and foremost responsible for developing and implementing a uniform customer centric corporate quality management system that is culturally impacting as a result of its invasive and directive influence on how the business operates and its behaviors. For the right individual, this role takes their experience and combines it with a significant amount of independence to define and architect something that could become legacy and the subject of books. This role is not only responsible for innovating and creating as well as owning and executing whatever you architect, this role will also have massive visibility routinely in front of the Board, routinely working with executive management, and routinely meeting with customers.

Requirements
Currently in a senior level Quality and Product Assurance management role within technologically complex capital equipment or related industries, this individual possesses +10 years of complex systems and hardware quality and product assurance management experience in progressively more challenging roles. With direct quality and product assurance experience supporting product development and manufacturing activities within a company that has scaled from $200M to +$500M in revenue, this individual is ideally possesses experience associated with the development of very complex products that span and integrate multiple technology disciplines (e.g., control systems, mechanical, electrical, software, lasers, optics, etc.). This individual ideally possesses experience with Asian semiconductor customers and systems manufacturing sites.

For More Information:
http://executive-advantage.com/ESI_DCQPA
There are additional links to downloadable information at the top of almost every page in the website. Specifically, at the top of - The Position Profile - page there is a link to - Download the Detailed Position Spec.

Contact:
Michael A. Rothstein
Managing Principal
Executive Advantage Group, Inc.
mrothstein@executive-advantage.com
Phone: 503-723.3134).

Department: Six Sigma

Job related criteria:

Responsible for working with Process Owners and Champions in order to manage projects that drive continuous and breakthrough operational improvements. Deliver significant operational improvements and financial benefit using knowledge of traditional process improvement tools and methodology; Act as a change agent to help instill a performance excellence culture and lead complex, highly visible projects across multiple departments or business units.

Self-directed, team player with 3 + years of healthcare experience required. Formal Lean, Six Sigma or other traditional performance improvement training coupled with experience in the application of SPC, process management and other advanced statistical techniques to drive operational improvements highly preferred.

Bachelors Degree in Business or technical discipline required; Masters degree preferred.

To apply, please visit our web site:
http://www.stmarymercy.org

Innovation Productivity Center (IPC)
Performance Improvement Consultant

Send Resume's to: nwfp-ipc@comcast.net

Job Brief
The primary responsibility of the IPC Performance Improvement Consultant is to research and develop more effective ways to improve organizational performance, and to educate and guide the Oregon and NW food manufacturing industry in the adoption of those practices.

Specifically, the person in this role will:

• Conduct high-performance audits in food processing companies to establish performance baselines and focus organizational resources toward optimal strategy and planning options.
• Fine tune or facilitate the implementation of performance measurement systems in companies - systems that accurately reveal high-value cost savings / revenue producing opportunities - and that continually inform and inspire the pursuit of high-demand output with the most efficient use of resources.
• Continually craft and refine an industry model for performance measurement and continuous improvement that simplifies adoption by other organizations.
• Facilitate organizational internalization of measurement tools and techniques, to include maintenance of the measures themselves, capable analysis, informative and graphic reporting of results to key personnel, regularly updating of the overall system, teaching maintenance skills to organizational staff, etc.
• Integrate measurement systems with other improvement programs that organizations may be engaged in.
• Market the essentials of productivity measurement to diverse audiences in open- enrollment seminars, and be prepared to make presentations on measurement to professional and trade associations, conferences, etc.
• Innovate continually - Our beginning assumption is that productivity improvement systems are inadequate to the needs of 21st century management challenges. The pace of change and the forces of global competition have created a need for much more ambitious and responsive information and action systems that optimally track the critical functions of today, while maintaining a continuing focus on the emerging innovation opportunities of tomorrow - and that artfully take advantage of the best waste elimination (LEAN) and quality assuring (SIX-SIGMA) tools and techniques.
• Write skillfully - measurement communications, publishable articles, online content, training materials, and other information-rich writings will be expected regularly.
• Mentor and grow client-company personnel so that they have the capability to execute and sustain all this stuff.

Qualifications

• Bright . . . resourceful . . . intuitively and insatiably curious. Creative, highly self- motivated, good humored . . . driven to make a difference. Number savvy, analytical, inquisitive, persistent, results focused. We're lookin' for a lot.
• Fluent with data synthesis and comfortable with basic statistics. Capable at filtering mountains of data into useful information using charts and graphs and formatting techniques and other creative communication devices.
• Proven abilities in project management to include persuasive oral communication skills (speaking and listening), effective tasking, prioritizing, assigning responsibilities, following up, etc. Able to engage, coordinate, educate and otherwise provide capable leadership to client-company personnel in the design of their productivity systems.
• Experience assessing organizational needs, determining priorities, and designing measurement systems to include the identification of key indicators, establishment of baselines, ambitious target setting, priority weightings, etc.
• Stand-up presentation skills - able to train audiences on performance measurement and related topics, using creative and effective techniques appropriate to adult learners.
• Accomplished writing skills. Examples of measurement communications, or facilitation materials and other writings you have developed should be available at the time of an interview.
• Personable . . . comfortable interacting with lots of client personalities, a diverse IPC staff, and all levels of organizations in general.
• Highly desired are strong and demonstrated skills implementing and/or maintaining productivity measurement systems in organizations as described in the responsibilities above. Five or more years experience in manufacturing is desirable (though less experience and extraordinarily keen aptitudes for the job will also be considered).
• Familiarity with Lean Enterprise (waste elimination) and Six-Sigma (variation minimization) systems are desirable.
• Proficiencies in Excel, Word, and PowerPoint are needed. Familiarity with Microsoft Access and graphic applications is desirable.
• . . . life-long learner, willing to take risks, keen to explore new ideas - demonstrably able and eager to innovate . .

Send resume's to:
nwfp-ipc@comcast.net