Medical Device Risk Engineer — ISO 14971 & FMEA

Rayner; Worthing; On-site; GBP 45,000 - 65,000; Full time

Benefits offered by this job

On-site Restaurant

Private Healthcare

Monthly Massages

On-site Parking

Annual Wellbeing Reimbursement

Pension Plan

Cycle-to-work Scheme

Enhanced Parental Pay

Referral Bonus

Job summary

Rayner in Worthing, West Sussex, is seeking an analytical engineer or technical specialist to own Product Risk Management for medical devices, developing and maintaining risk documentation and leading cross-functional risk reviews. You will facilitate risk assessments and work with R&D, quality, regulatory and manufacturing teams to ensure controls are current, compliant and effectively implemented.

Training will be provided on ISO 14971 and related standards.

Qualifications

• Broad technical awareness across product design, manufacturing and software-controlled systems.
• Competence in key Microsoft Office packages (Outlook, Word, Excel, Teams, SharePoint).
• Strong analytical and problem-solving skills; identify trends and challenge assumptions.
• Experience processing large data in a structured environment.
• Proven ability to generate high-quality Technical Documentation.
• Knowledge of medical device regulations and standards.
• Familiarity with ISO 14971, ISO 13485 or Design Control processes.
• Experience with risk assessment methodologies (FMEA, FTA, Hazard Analysis).
• Experience in regulated environments (medical devices, pharmaceuticals, aerospace, etc.).
• Engineering qualification or relevant technical discipline.

Responsibilities

• Lead the development and maintenance of Product Risk Management documentation for new and existing medical devices, working within established company procedures and international standards.
• Facilitate cross-functional risk reviews, ensuring input from engineering, manufacturing, quality, clinical and regulatory stakeholders.
• Capture and document risk assessments relating to product design, manufacturing processes and product use, ensuring information is accurate and traceable.
• Represent the R&D Product Risk Management function on multi-disciplinary teams working on research, NPD and regulatory projects.
• Work with R&D, Vigilance, Quality, Validation, Process Engineering, Production and external suppliers to maintain Product Risk Management files.
• Ensure that Risk Control Measures are appropriate and up to date as processes improve.
• Maintain a high standard of professional and technical knowledge through training, publications, networks and societies.

Skills

Analytical thinking

Detail-oriented

Risk management

Cross-functional collaboration

Problem-solving

Systems thinking

Technical curiosity

Education

Engineering degree or relevant technical discipline

Tools

Microsoft Office

Job description

Rayner in Worthing, West Sussex, is seeking an analytical engineer or technical specialist to own Product Risk Management for medical devices, developing and maintaining risk documentation and leading cross-functional risk reviews. You will facilitate risk assessments and work with R&D, quality, regulatory and manufacturing teams to ensure controls are current, compliant and effectively implemented.

Training will be provided on ISO 14971 and related standards.