High-Precision Medical Device Specialist
Vor 2 Tagen
We are seeking a highly skilled and innovative individual as a Clinical Product Engineer to join our team at Medartis AG.
About the RoleThe successful candidate will be responsible for designing and developing custom and patient-matched medical devices for our CMX service, working closely with surgeons, R&D, manufacturing, and regulatory teams to deliver high-quality products on time.
This is an integral role that requires strong problem-solving skills, attention to detail, and excellent communication skills. The ideal candidate will have a bachelor's or master's degree in biomedical engineering, mechanical engineering, or a related field, and relevant work experience in a clinical environment with 3D modeling or surgical planning.
The selected candidate will also possess excellent English language skills, both written and spoken, with German skills being an advantage. Proficiency in 3D modeling, familiarity with additive manufacturing, 3D printing, and other digital fabrication methods are essential for this role.
We are looking for someone who understands medical device regulations and industry standards, such as ISO 13485 and FDA requirements, and can convey complex technical information clearly to clinical partners and cross-functional teams.
Responsibilities- Design & Development: Design and development of custom and patient-matched medical devices for Medartis CMX service
- Cross-Functional Collaboration: Collaborate closely with surgeons, R&D, manufacturing, and regulatory teams to deliver the custom made or patient matched devices on time to the operation room
- Quality & Compliance: Ensure design and manufacturing processes comply with relevant medical device regulations (e.g., ISO 13485). Partner with Quality and Regulatory Affairs to maintain and improve quality standards
- Continuous Improvement: Participate in design reviews, risk assessments, and product validation activities. Identify opportunities to enhance product performance, reduce costs, and optimize manufacturing processes
- Project Management: Coordinate cases and maintain clear case documentation
- Bachelor's or master's degree in biomedical engineering, mechanical engineering, or a related field
- Working experience in a clinical environment with 3D modeling or surgical planning
- Excellent English skill in both written and spoken, German skills are an advantage
- Proficient in 3D modeling. Familiarity with additive manufacturing, 3D printing, and other digital fabrication methods
- Understanding of medical device regulations and industry standards (e.g., ISO 13485, FDA requirements)
- Strong problem-solving skills, with the ability to interpret clinical requirements and translate them into innovative product solutions
- Ability to convey complex technical information clearly to the clinical partners and cross-functional teams
This is a unique opportunity to work in a rapidly growing, international company with a focus on quality and service provision. We offer a dynamic work environment, modern infrastructure, and a range of benefits, including health insurance, support options for retirement, and loyalty rewards.
About MedartisMedartis is a leading medical device manufacturer specializing in high-precision implants for the surgical fixation of bone fractures, fusions, and osteotomies. Our motto of 'Precision in Fixation' reflects our commitment to innovative development and stringent quality standards, with the goal of improving the patient's quality of life.
We look forward to receiving your complete application and exploring how you can contribute to our team's success.
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