Join to apply for the Design Assurance Engineer - IVDR role at Abbott.
About Abbott
Abbott is a global healthcare leader, 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 – creating more possibilities for 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.
Job Location
Galway, County Galway, Ireland
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 across Europe, Asia, and the US. The team is responsible for Design Control throughout the lifecycle of NPI projects, from ideation through to product launch including sustainment, for the 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 who will strengthen the team through the 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 and ensure compliance across all our core and extended teams – R&D, Marketing, QA, RA, Clinical Operations, and Manufacturing.
Please note this position is a 12‑month FTC.
Responsibilities And Duties
* Promote awareness of regulatory and customer requirements throughout the organization.
* Remediate current Design Control procedures and practices across sites to standardize to “best‑in‑class” design controls. Liaise with quality systems and regulatory affairs personnel to ensure compliance and drive alignment and harmonization.
* Deploy effective training collateral to ensure compliance with design control policies with the core teams, extended teams, and relevant functions within the business unit.
* Embed Design Assurance in all stages of 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.
* Provide ongoing 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 labeling, attend design reviews, coordinate and facilitate completion and update of design risk management documentation, and act as independent reviewer for all design activities including design changes.
* Escalate design control concerns/ issues in a timely manner to ensure project schedule maintenance.
* Support design control for audits including Abbott corporate audits and external regulatory/governing body audits (e.g., FDA/WHO).
* Work in a matrix organization 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 (ISO 13485/FDA).
* Formal training in medical device risk management, process validation, software validation, and problem solving would be beneficial.
* Excellent data analytics skills.
* Proven ability to work well as part of a team and independently.
* Excellent communication skills to support virtual project requirements.
* Clear demonstrated experience working in a diverse cultural environment.
* Excellent presentation skills to facilitate communication throughout the organization. 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.
Seniority level
* Entry level
Employment type
* Full‑time
Job function
* Quality Assurance
Industries
* Hospitals and Health Care
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