Keywords: mechanical testing, medical device, regulated industry, Medical Device Directive / Medical Device Regulation (MDD/MDR), ISO 13485, mechanical, design, human factors, industrial design.
For consultant assignments within the pharmaceutical industry we are now looking for engineers with experience of medical device or other highly regulated industry. Examples of regulated industry may be: automotive, aviation, pharmaceutical and chemical industry, and oil and gas industry. Our clients have several assignments were you will work with medical devices. Your works tasks may include:
- Mechanical testing of medical devices
- Development and validation of mechanical test methods
- Sourcing, installation and qualification of test equipment
- Generate documentation for Design History Files (DHF) of medical devices.
- Translation of User needs into technical Design Input Requirements
- Evaluate and select materials, for example durability.
- Contribute with your expertise within Human Factors /Usability, specifically focusing on the interactions between people and the mechanical devices.
- Initiate and support risk management
To qualify for the assignments you are a mechanical engineer, design engineer or a test engineer. You may also be an industrial design engineer or another type of engineer with a degree in Cognitive Psychology. Preferably, you have experience of medical device or other highly regulated industry. You have experience in some of the areas below:
- Medical Device Directive / Medical Device Regulation (MDD/MDR)
- Quality Management System for medical device, ISO 13485 and other relevant standards such as Food and Drug Administration (FDA) and International Electrotechnical Commission (IEC)
- Experience in creating Design History File (DHF) documentation
- Current Good Manufacturing Practices (cGMP’s)
- FDA 21 CFR 820 and FDA 21 CFR 4
- Pro/Engineer Creo experience or other CAD (Solidworks or CATIA)
- The international standard IEC 62366 medical devices - Application of usability engineering to medical devices
- FDA Human Factors guidance and The Medicines and Healthcare products Regulatory Agency (MHRA) guidance
It is important for us that all skills on the labour market should be used. We welcome all applicants and strive for diversity.
Deadline for applications: 2018-04-23. Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application at your earliest convenience!
Selection and interviews will take place on a continuous basis. The post may be filled before the closing date, so please apply as soon as possible.
For information: Sara Kuikka firstname.lastname@example.org 0725-487688
Description of the organisation/company:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the world’s second largest company within recruiting and staffing.