What are the responsibilities and job description for the Mechanical Engineer / Senior Engineer position at OMEC Medical NV?
About OMEC:
OMEC supplies high quality products with advanced functionality for the Medical Surgery and Biomedical Diagnostic industries that leverage our expertise with optical instrumentation design and commercialization.
About the role:
- Design, develop, and analyze mechanical components and systems for novel medical devices.
- Create detailed 3D models and 2D drawings using CAD software (e.g., SolidWorks, Creo).
- Rapidly iterate on designs based on feedback from testing, simulations, and regulatory requirements.
- Conduct design reviews and present design concepts to cross-functional teams.
- Develop and execute test protocols and analyze test data to validate design performance.
- Collaborate with other engineers (electrical, software, biomedical) to ensure system-level compatibility.
- Ensure compliance with relevant regulatory standards (e.g., FDA regulations, ISO standards).
- Support the preparation of technical documentation for regulatory submissions.
- Contribute to the development of intellectual property (patents, trademarks).
Qualifications and Requirements:
Required：
- Bachelor’s degree (B.S.) in engineering (electrical, mechanical, or industrial), physics, or chemistry required.
Preferred:
- Experience with FEA/CFD analysis.
- Experience with medical device manufacturing processes (e.g., injection molding, machining, assembly).
- Knowledge of regulatory requirements for specific medical device types.
- Experience with Agile development methodologies.
- Experience working in a regulated environment such as ISO 13485.
- Experience in an optomechanical manufacturing environment preferred.
- Experience in training staff in new and existing processes preferred.
- Experience in ensuring that manufacturing procedures follow safety and environmental regulations preferred.
- Ability to occasionally travel preferred.
- Ability to speak Chinese (preferred but not required to fulfill the duties of this role).
Benefits:
- 401(k) with company match
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Paid time off
- Paid sick leave
- Paid Holidays
Supplemental pay types:
- Bonus
Work Location: One location
