Product Evaluation Engineer

The primary objective for the PE function is to improve the success of New Product Developments (NPD).  The PE Engineer has responsibility for the generation of documentation and conduct of testing to support PE activities within NPD projects.  The PE Engineer shall ensure that valid and robust data is obtained and documented during execution of validation and verification activities.

 ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Produce design verification protocols, reports andperform the product testing where necessary
• Design, develop and validate appropriate test methods
• Participate in NPD phase reviews, presenting the results and progress summaries of activities for which they are responsible
• Ensure clinical model definition – translation of the intended clinical usage of a device into a definition in quantifiable engineering terms of the operational and environmental conditions that the device must withstand
• Participate in risk management and FMEA exercises
• Review and contribute to the necessary design input documents
• Interface with design, marketing, clinical, manufacturing and quality teams to ensure the PE function is fully integrated within the NPD team
• Conduct programmes for extended life / reliability testing of new products
• Analyse and report on Customer Enquiries
• All other essential related duties as required

• Graduate or equivalent calibre in science, engineering or technology discipline with demonstrable relevant experience, preferably within the medical device industry
• Experience of quality or product test fields
• Good organisational skills
• Attention to detail
• Concern for quality and standards
• Customer focus
• Written communication skills

KNOWLEDGE, SKILLS AND ABILITIES:

Knowledge of the core concepts of the listed areas:

• Test method validation
• Reliability engineering
• Statistical analysis
• Electronic/Mechanical/Quality engineering
• RF technology
• ICE 60601
• Packaging
• Life Testing
• Sterilisation
• Risk Management
• FMEA