Design Assurance Engineer - IVDR job opportunity at Abbott.

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DateMore Than 30 Days Ago bot
Abbott Design Assurance Engineer - IVDR
Experience: Highly Experienced
Pattern: full-time
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loacation Ireland - Galway, Ireland
loacation Ireland - Galw..........Ireland

      JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world:  in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today our 115,000 Abbott colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve. Description The global   Design Assurance   team for IDEM, the Infectious Diseases Emerging Market Business Unit, supports   R&D , Marketing, Clinical Operations, RA, QA and manufacturing functions based in Europe, Asia and US. The team is responsible for   Design Control   throughout the lifecycle of NPI projects, from   ideation   through to   product launch   including sustainment, for realization of our Lateral Flow Diagnostic Devices. The team supports a rapidly expanding business unit within Abbott. To ensure we can rapidly expand our   Design Assurance   capability, we are recruiting a   Design Assurance   Engineer that will strengthen the team through implementation of best practice   design controls   within our projects. The   Design Assurance   Engineer role will be instrumental in   shaping   the NPI Project deliverables to support our IDEM new   product development   pipeline. They will provide direction to and ensure compliance across all our Core Teams and Extended Teams –   R&D , Marketing, QA, RA, Clinical Operations and Manufacturing. The specific role initially will be focused on a number of exciting new   product development   opportunities and participate on cross-site or cross Business Unit Core Teams to ensure standardisation of project deliverables in compliance with best-in-class   design controls . Please note this position is a 12 month FTC Responsibilities and Duties Promotes the awareness of regulatory and customer requirements throughout the organization. Remediation of current   Design Control   procedures and practices across sites to standardise to “best in class”   design controls . Liaise with   quality   systems and regulatory affairs personnel within the Business Unit to ensure team’s compliance and to drive alignment and harmonization. Deployment   of effective training collateral to ensure compliance to   design control   policies with the Core Teams, Extended teams and relevant functions within the Business Unit. Embed   Design Assurance   in all stages of the design concept and feasibility to support   R&D   through specification setting, test development and provision of   statistical sampling   to ensure robust prototypes and design at design freeze. Support new test development and appropriate test method validation. Provision of on-going risk management,   design control ,   quality   systems and overall   design assurance   expertise and leadership to the Project Core and Extended teams. Perform technical reviews of   design documentation   and labelling, attend at   design reviews ,   coordinate   and facilitate completion and update of design risk management documentation and acts as independent reviewer for all design activities including design changes. Escalate where appropriate   design control   concerns/ issues in a timely manner to ensure project schedule maintenance. Design Control   Support for audits including Abbott Corporate Audits and external Regulatory/ Governing Body audits (e.g. FDA/ WHO). Ability to work is a matrix organisation where project deliverables are accountable to the Program/ Workstream Leader. Requirements Primary Degree level qualification in Science, Engineering or Technology, plus 2-3 years of   Quality Engineering /   Design Assurance   work experience within a regulated environment (ISO13485/ FDA). Formal training in Medical Device Risk Management,   Process Validation ,   Software Validation   and problem Solving would be beneficial. Excellent data analysis skills. Proven ability to work well as part of a team and on own. Excellent communication skills to support virtual project requirements. Clear demonstrated experience in working in a diverse cultural environment. Excellent presentation skills to facilitate communication throughout the organisation. In addition, excellent use of virtual communication technology is required for effective workshop leadership and change management. Travel pending company policy, global and country regulations to Asia and Europe.       The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Operations Quality       DIVISION: ID Infectious Disease          LOCATION: Ireland > Galway : Parkmore East Business Park       ADDITIONAL LOCATIONS:       WORK SHIFT: Ie - 37.5Hst0 (Ireland)       TRAVEL: Not specified       MEDICAL SURVEILLANCE: Not Applicable       SIGNIFICANT WORK ACTIVITIES: Not Applicable                  

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