Product Risk Management Specialist

Rayner Surgical Group; Worthing; On-site; GBP 50,000 - 75,000; Full time

Benefits offered by this job

On-site Restaurant

Private Healthcare

Wellbeing initiatives

Pension Plan

Cycle-to-work

Referral Bonus

Job summary

Rayner Surgical Group is seeking an analytical engineer or technical specialist to support product risk management for medical devices. The role focuses on risk identification, documentation, and cross-functional collaboration across engineering, quality, regulatory and clinical teams.

On-site at Global HQ in Worthing, the role offers training on ISO 14971 and requires an ability to handle large data, develop risk assessments, and maintain documentation to high standards in a regulated

Qualifications

• Broad technical awareness across product design, manufacturing and software systems.
• Proficiency in MS Office (Outlook, Word, Excel, Teams, SharePoint).
• Strong analytical and problem-solving skills with trend identification.
• Ability to process large data sets methodically in structured environments.
• Proven ability to generate high-quality technical documentation.

Responsibilities

• Lead development and maintenance of Product Risk Management documentation for medical devices.
• Facilitate cross-functional risk reviews with engineering, manufacturing, quality, clinical and regulatory.
• Capture and document risk assessments for design, manufacturing and use of products.
• Represent R&D Product Risk Management on multidisciplinary teams in projects (research, NPD, process improvement, regulatory, clinical).
• Coordinate with R&D, Vigilance, Quality, Validation, Production and suppliers to maintain risk management files.
• Ensure Risk Control Measures (SOPs, Design Verification, Biological Evaluation) are current with evolving processes.
• Pursue ongoing professional development to maintain technical knowledge and network with professionals.

Skills

Broad technical awareness

MS Office

Analytical skills

Data handling

Technical documentation

Education

Engineering degree

Tools

ISO 14971

FMEA

FTA

Hazard Analysis

Design Controls

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:

Essential

• 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

Desirable

• 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