Are you looking for a position where you are responsible for developing and improving assembly and testing processes for the manufacture of ophthalmic instruments and devices? Do you have knowledge and experience with international Medical Device regulations and standards? And are you always curious about new developments in your field? Then keep reading, we may have the perfect opportunity for you!
You will be held responsible for maintaining and improving current processes next to developing new processes for operations. You will collaborate closely with your colleagues from Manufacturing Engineering, Operations, R&D and Quality. New processes will be tested extensively, the data will be analyzed (DOE) and validated (IQ, OQ, PQ).
Tasks and Responsibilitie
- Set-up risk analysis plans for assembly and test processes (pFMEA)
- Design and improve assembly processes and implementation at the production floor (NPI)
- Set User Requirements Specification
- Use data analytics and simulation tools to test performance and optimize the process (DOE)
- Validate assembly and test processes and/ or specific equipment (FAT,SAT,IQ, OQ, PQ)
- Analyzing and solving process problems with machines (RCA, DMAIC).
- Setup preventive maintenance infrastructure (TPM).
- Assessing design solutions for manufacturability (DFA, DFT)
- Supervising and assessing 0-series and recording the results.
- Preparing production documents (assembly manuals).
- Training and supervising production personnel and final inspectors in production
- Reporting on progress of projects, hours spent etc.
Knowledge and Experience
- Regulations and standards in Medical Devices (ISO 13485, 21 CFR Part 820, EN ISO 11607-2, EN ISO 868-5, ISO 14971 etc.)
- Familiar with clean room, cleaning and sterile barrier processes
- Coordinating risk management activities (gathering stakeholders, writing pFMEA, etc.)
- Set-up of Design Of Experiments and familiar with data analysis software 9Minitab)
- Preparing and executing validation activities. Writing validation documentation (IQ OQ PQ)
- Experience in coordination and planning of validation activities and aligning with stakeholders from different departments.
- Excellent written and oral communication skills in Dutch and English.
- A college education in a technical field such as Mechanical Engineering, Or comparable level obtained through experience.
- At least 10 years' work experience in a position involving collaboration with multidisciplinary teams in a Medical Devices production environment.
Does DORC make you happy?
Does working for you mean working together? Realizing 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 organization 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 and 13 adv-days 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. 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 Advanced Manufacturing Engineer?
Are you up for this? Then apply directly (in English) via the red button! Do you still have questions? Then contact Anne Prins-Hooijmans our Global Recruiter: anne.prins.ext@zeiss.com.
An assessment or the request for a Certificate of Good Conduct (VOG) may be part of the selection process.