Product Risk Management Specialist

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

We are looking for an analytical and detail-oriented engineer or technical specialist who enjoys understanding how products can fail, identifying risks, and working with multidisciplinary teams to develop practical solutions. Whilst experience with medical device risk management is advantageous, we are equally interested in candidates who can demonstrate strong problem-solving skills, technical curiosity, systems thinking and the ability to work with complex information.

We recognise that excellent risk management professionals can come from a variety of technical backgrounds. Full training and mentoring will be provided on Rayner's Risk Management processes, tools and the practical application of ISO 14971.

Please note that this role is based on-site at Global HQ in Worthing, West Sussex.

What You'll Be Doing:

• Lead the development and maintenance of Product Risk Management documentation for new and existing medical devices, working within established company procedures and international standards. Training will be provided on the specific application of ISO 14971 where required.
• Facilitate cross-functional risk reviews, ensuring appropriate input is obtained 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, traceable and maintained in accordance with company procedures
• As part of the R&D Product Risk Management team, represent the R&D Product Risk Management function on multi-disciplinary teams working on research, NPD, process improvement, regulatory and clinical projects, providing information, guidance and support on all product risk management aspects.
• Work closely with R&D, Vigilance, Quality, Validation, Process Engineering, Production and external suppliers (factored products only) to effectively and efficiently maintain Product Risk Management files in accordance with company SOPs and international standards.
• Ensure that Risk Control Measures (e.g. Manufacturing SOPs, Design Verification and Biological Evaluation activities) are appropriate and up to date as company processes and practices continuously improve.
• Maintain a high standard of professional and technical knowledge by attending educational training/workshops, reviewing professional publications, establishing networks, and participating in professional societies.

What Experience & Skills You Will Need:

• Broad technical awareness and the ability to understand engineering concepts across product design, manufacturing and software-controlled systems.
• Competence in key Microsoft Office packages (including Outlook, Word, Excel, Teams, SharePoint)
• Strong analytical and problem-solving skills, including the ability to identify trends, draw logical conclusions and challenge assumptions.
• Demonstrable experience of effectively processing large amounts of data and Information In a methodical manner within a highly 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 such as FMEA, Fault Tree Analysis (FTA), Hazard Analysis or similar techniques.
• Experience working in a regulated or highly controlled environment (e.g. medical devices, pharmaceuticals, aerospace, automotive, defence or other safety-critical industries).
• Qualification in Engineering or relevant technical discipline

What We Can Offer You:

• On-site Restaurant for affordable, convenient meals
• Private Healthcare (access to remote GP & Counselling) for peace of mind
• Monthly Massages to relax and recharge
• On-site Parking for convenience and cost efficiency
• Annual Wellbeing Reimbursement to care for your mind and body
• Pension Plan to secure your future
• Cycle-to-work Scheme to stay active and eco-friendly
• Enhanced Parental Pay to support new families
• Referral Bonus to benefit from recommending talent