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...
Tasks and responsibilities:
- 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
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
Does DORC make you happy?
Does working for you mean working together? Realising surgical devices together that help to make people see again? With a hands-on and both legs on the ground mentality? Do you want to work for an organisation where you get freedom and responsibility? Where you are fully stimulated to come up with new ideas? And where innovation, quality and technology are woven into the DNA? Then DORC is the place for you.
Would you like to know more about working at DORC? Then read on here.
What does DORC have to offer you?
At DORC, you play at top level. It is therefore only logical that we reward you as a top player. You can expect the following:
- 27 holidays for a 40-hour full-time job
- 8% holiday pay
- 13th month
- Bonus scheme
- A travel allowance of € 0.23/km
- And a non-contributory pension, which means you will receive a substantially higher net salary
What else can you expect from us? Every opportunity to learn and grow. Your own laptop and smartphone. And a fantastic company restaurant full of delicious, fresh products.
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.