Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
We are seeking an experienced, high caliber Configuration Specialist to manage Design Inputs, Risk Management, Design Verification and Validation data in IBM Collaborative Lifecycle Management (CLM) tool, to ensure effective quality compliance, configuration traceability and release management.
* Lead systems engineering efforts for complex diagnostic systems; responsibilities include managing requirements, risk and test information for Hardware, Software, Commodities (Disposable) and Assay (Reagents) in IBM CLM tools. Managing Global Configurations, Components, Streams and Baselines for different diagnostic programs and release records for inclusion in Design History File.
* Identify requirements for new and existing diagnostic systems, including Instrument, Commodities, and Assays, through internal subject matter expert consultation, competitive review, risk management process outputs and voice of customer solicitation. Lead risk management activity, including Design FMEA documentation, employing other risk analysis methodologies as appropriate.
* Assist in development and refinement of system architecture requirements, including clear definition of subsystem interfaces. Plan documentation and testing activity in CLM for multiple ongoing projects/releases/streams based on business priority and program resource availability.
* Comprehend Operating Procedures or Process documents and convert them into tool requirements for CLM administrator to configure and customize the tool.
* Collaborate with global sites across all functional areas to establish and maintain industry standard processes that maximize productivity and deliver coordinated, high quality production releases.
* Perform informal and validation testing to ensure upgrades/patches did not impact key features of the tool.
* Create best practice documents and provide training to users.
Works in a standard office environment and uses general office equipment (PC, telephone, copier, etc.) Majority of time is spent working on a PC, managing data, guiding and responding to users either via email or telephone.
* Must be familiar with medical device design control processes or any other regulated industry like Defense, Automotive etc.
* Candidates should be able to distinguish between good and bad requirements instances. Familiarity with systems engineering standards.
* Good verbal and written communication skills to efficiently document design control data and collaborate with global users.
* Hands on experience with IBM CLM or similar collaborative requirements/test management tools.
* Previous experience with ISO 14971 or similar Risk Management process will be extremely helpful.
* Experience with products registered through both 510(k) process and CE mark will be helpful.
* 5 or more years progressive work experience in FDA regulated Medical Device or any regulated industry managing requirements, risk and/or test management data.
* 2 or more years work experience with collaborative data management tool like IBM DOORS, IBM CLM, JAMA, Siemens Polarion, PTC Integrity etc.
LOCATION:United States > Irving : LC-02
TRAVEL:Yes, 10 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf