Our client is committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world - in nutrition, diagnostics, medical devices and branded generic pharmaceuticals - that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Description
The global Infectious Disease (ID) Design Assurance, the ID 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 Senior Design Assurance Engineer specialising in Risk management that will strengthen the team through implementation of best practice Risk management processes.
The Senior Design Assurance Engineer specialising in Risk management role will drive end‑to‑end product risk management across multiple development and manufacturing sites for in vitro diagnostic (IVD) products and systems. This role leads the planning, execution, and continuous improvement of risk management files (RMFs), ensuring compliance with global regulations and standards, while enabling safe, effective, and reliable products. They will partner closely with R&D, Manufacturing, Clinical/Medical Affairs, Regulatory Affairs, and Post‑Market Surveillance to proactively identify, evaluate, mitigate, and monitor risk throughout the product lifecycle.
Responsibilities and Duties
- Own risk management plans, hazard analyses, FMEAs (Design/Use/Process), Fault Tree Analysis (FTA), and risk/benefit assessments across multiple IVD programs.
- Establish and maintain Risk Management Files (RMF) aligned to ISO 14971 and EU IVDR (Annex I GSPRs); ensure consistent application across sites.
- Integrate Human Factors/Usability Engineering risk inputs (per IEC 62366‑1) and cybersecurity risk inputs (e.g., threat modelling) into RMFs.
- Drive risk activities from concept through launch and post‑market: risk planning, risk acceptance criteria, verification/validation linkage, and risk control effectiveness.
- Harmonize risk management processes, templates, and tools across sites; facilitate risk reviews/boards and teach‑backs.
- Coach engineers and teams on best practices (e.g., severity/occurrence/detection rating calibration, harm mapping, foreseeable misuse, use‑error analysis).
- Ensure risk management is embedded in design control deliverables (e.g., design inputs/outputs, V&V plans, clinical/performance evaluation inputs).
- Risk Management Support for audits including our clients Corporate Audits and external Regulatory/ Governing Body audits (e.g. FDA/ WHO). Take the lead and front the team’s participation in audits.
Requirements
- Primary Degree level qualification in Science, Engineering or Technology, plus 5 years of Quality Engineering/ Design Assurance work experience, with 3 years in Risk Management within a regulated environment (ISO13485/ FDA), .
- Formal training in Medical Device Risk Management 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 (approx. 25%).
For a confidential discussion on the role please contact Chris O Toole.
