R&D Engineer - Requirements Engineering (For the duration of 7 months)

at  DORC International

R&D Engineer - Requirements Engineering (For the duration of 7 months)
We are looking for a hands on R&D Engineer - Requirements Engineering. The engineer is responsible for activities that include but are not limited to design, simulation, prototype build, test, documentation and risk management to develop and/or maintain and continuously improve products in the field of ophthalmic surgery. This may also include the development and improvement of production processes. All activities need to be carried out in conformity with international regulations, safety and performance standards as applicable to medical devices. The incumbent will likely be part of one or several project teams, led by a project manager. If you are interested, please read on…

SKILLS AND QUALIFICATIONS:

• Technical Bachelor’s degree in Biomedical Engineering or similar
• Experience with the MDR, standards, Medical Device and medical instruments
• Knowledge of Polarion
• Minimal 3 years of industry experience in a comparable area of responsibility including solid understanding of design verification process
• Write and maintain the product requirements from Customer level to System Level, decomposed into subsystems, modules, software levels
• Taking into account regulatory requirements, safety requirements based on Risk Analysis, Usability requirements
• Create traceability
• Manage the set of requirements throughout the development and verification and validation of the requirements
• Technical File writing conforming to international standards and regulations (e.g. MDR, FDA, ISO, IEC) in order to prove product design, performance, and safety

DID YOU KNOW …?

DORC, short for Dutch Ophthalmic Research Center, manufactures equipment, instruments and liquids used in eye surgery.
DORC is a ZEISS company, an internationally leading technology enterprise that develops, manufactures and sells highly innovative products and solutions in a variety of business fields, such as medical technology. As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities.
Will you be our new R&D Engineer - Requirements Engineering?
Are you up for this? Then apply directly via the red button! Do you still have questions? Then contact Monique Meiling our Global Recruiter: m.meiling@dorcglobal.com.
Country
The Netherlands
Job Category
R&D
Education
Master
Hours
40
Job Type: Full-time
Work Location: In perso

• Translate user needs into design requirements, assuring full traceability
• Create complete project documentation (Technical File); according to international medical device/ good documentation practices standards
• Participate in risk management activities / FMEA
• Support verification & validation activities
• Collaborates with QA/RA to assure completeness of technical documentation