Job
- Level
- Senior
- Job Field
- Test/QA
- Employment Type
- Full Time
- Contract Type
- Permanent employment
- Location
- Bad Homburg vor der Höhe
- Working Model
- Onsite
Job Summary
In this role, you support system-level quality assurance through system testing, process optimization, and FMEA facilitation to ensure the safety of medical devices.
Your role in the team
- Consulting and support in quality assurance at the system level, including but not limited to system integration testing, interface testing, release readiness, and defect management.
- Collaboration with interdisciplinary engineering teams from the early development phases to provide input and support in quality assurance.
- Evaluation of modern methods for system and electronics quality, tracking progress, and implementing improvement plans.
- Definition and monitoring of quality metrics as well as communication of risks and quality status to stakeholders.
- Development of project-specific quality strategies and their operationalization through tailored measures.
- Support in managing errors, deviations, anomalies, and non-conformities.
- Identification of opportunities to improve system quality processes, methods, and templates through gained insights and feedback.
- Planning, coordination, support, review, and moderation of design FMEAs, especially for electronic and mechatronic subsystems, to identify and address potential design weaknesses early in the development process.
- Consulting development teams on FMEA methodologies (e.g., dFMEA, System FMEA) as well as on tool application, templates, and process optimization.
- Improvement of existing processes related to the Product Life-Cycle and support for compliance with current regulatory requirements for medical device systems.
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Our expectations of you
Education
- Successfully completed technical degree in a natural science or engineering discipline.
Qualifications
- In-depth understanding of product development processes and quality methods at the system level.
- Knowledge of relevant regulations and standards for medical devices, such as ISO 13485, ISO 14971, the IEC 60601 family, and related development standards, is advantageous.
- Good and professional relationships as well as communication with colleagues and internal as well as external clients.
- Strong communication skills due to interfaces with other departments.
- Willingness to occasionally travel for work.
- Excellent spoken and written proficiency in German and English.
Experience
- At least 5 years of professional experience in product development within regulated environments, including a minimum of 3 years in the medical technology sector.
- Experience in Systems Engineering and/or Electronics Development.
- Experience in the development of medical devices or in another regulated industry.
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What we offer
- There is a lot to discover at Fresenius Medical Care – regardless of your area of expertise or your level of experience. Everything is geared towards your professional development.
- Whether visible or in the background - you help to make better medicine available to more and more people worldwide.
- Individual opportunities for self-determined career planning and professional development.
- A corporate culture that fosters innovative thinking — to collaboratively find the best, not the fastest, solution.
- Many dedicated people with a wide range of skills, talents, and experiences.
- The advantages of a successful global corporation with the collegial culture of a medium-sized company.
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Benefits
More net
- 🏝️Summer and Christmas Bonus
- 🍰Employee Stock Option
- 👴🏻Company Retirement Provision
- 👷♂️Additional Insurance
Health, Fitness & Fun
Work-Life-Integration
Food & Drink
Topics that you deal with on the job
Job Locations
This is your employer
Fresenius Medical Care AG & Co. KGaA
Fresenius Medical Care is a world-leading provider of dialysis products and therapies. With over 40 years of experience in dialysis and cutting-edge research, we offer our patients the best possible treatment.
Description
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Pharmaceutical Sector, Chemical Industry, Biotech
Dev Reviews
by devworkplaces.com
Total
(2 Reviews)3.4
Workingconditions
4.3Engineering
3.0Career Growth
3.0Culture
3.5
Design Quality Engineer
- Location
- Bad Homburg vor der Höhe
- Working Model
- Onsite
- Diversity
- Open for all genders
