Overview:
We are seeking a Mechanical Engineering Specialist to support EU MDR compliance efforts for our Spine Division. This role involves the creation of technical documentation, test reports, and the development of compliance strategies for medical devices, including implantable devices and instruments. The position is part of the R&D team and requires close collaboration with testing labs and other divisions.
Key Responsibilities:
- Define project scope by evaluating product characteristics (e.g., materials, coatings, dimensional requirements) and supplier capabilities.
- Identify worst-case materials and parts for testing and analysis.
- Utilize mechanical engineering expertise to perform detailed reviews of capability studies and other testing for comparison across divisions.
- Develop and execute capability studies in partnership with the testing lab.
- Prepare comprehensive Engineering Analysis documents and technical reports.
- Serve as a subject matter expert (SME) for laser marking and develop the AIDC 2D barcode compliance strategy.
- Apply engineering, biomechanical, and biological principles to the design, development, and evaluation of medical devices.
Requirements:
Education: Bachelor's degree in Engineering or a related field (required).
Experience:
- Minimum of 2 years of relevant experience.
- Expertise in mechanical engineering, technical writing, and compliance documentation.
- Familiarity with testing methodologies and capability studies.
Top Skills:
- Ability to define project scope and evaluate product and supplier characteristics.
- Proficiency in mechanical engineering analysis and technical documentation creation.
- Strong collaboration with test labs to develop and execute capability studies.
Other Qualifications:
- Attention to detail and ability to make evaluative judgments based on factual information.
- Independent work ethic with minimal supervision required.
- Prior experience in medical device development or R&D, particularly with implantable devices and instruments.
- Knowledge of EU MDR compliance requirements