Senior Mechanical Engineer
5 days ago
We are seeking a highly skilled Senior Mechanical Engineer to join our team in Belmont, CA. As a key member of our cross-functional team, you will be responsible for designing and developing components, fixtures, and test equipment systems to support the development of novel intraocular lens devices and technologies.
Key Responsibilities- Design and develop components, fixtures, and test equipment systems to support the development of novel intraocular lens devices and technologies.
- Conduct experiments and root cause analysis for emerging manufacturing or design defects.
- Work closely with subject matter experts from a cross-functional team of mechanical, optics, manufacturing, and materials scientists to investigate and evaluate existing technology and design new methodology, materials, or equipment as needed.
- Develop and execute design verification/validation test protocols and document results in test reports.
- Prepare and present study protocols, technical reports, technical presentations, and other supporting documents for internal and external submissions.
- Participate in cross-functional R&D activities as a functional representative on various core-team and sub-team project meetings.
- Work with suppliers and contract manufacturers to build the capability to support manufacturing scale-up.
- Monitor the field for new developments in ophthalmic surgery practice, manufacturing technology, IOL, and delivery system development to support the development of new products in accordance with the IOL pipeline strategy.
- Bachelor's Degree or Equivalent year of directly related experience.
- The ability to fluently read, write, understand, and communicate in English.
- 2+ years of relevant experience.
- Experience in product development from ideation to pilot line scale-up.
- Experience in fixtures and tooling design (SolidWorks preferred).
- Knowledge of performance metrics, statistical analysis, and data mining using SAS, JMP, or Minitab.
- Fundamental Lean Six Sigma knowledge for problem-solving and/or process optimization.
- Self-driven and willing to work as part of the team in a dynamic fast-paced environment.
- Experience in developing metrology systems and executing Gage R&R.
- Experience with equipment qualification (IQ/OQ).
- Experience in characterizing process capabilities using design of experiment.
- Excellent verbal, written, and presentation skills to communicate accomplishments/risks to peers, management, and suppliers.
- Medical device class III experience.
- Fundamental understanding of ISO 13485 medical device regulation.
- Experience with manufacturing process automation.
- Injection mold tooling development and flow analysis.
- Optical component development using diamond turning lathes.
- Data collection and management system.
- Database development and analytics (SQL, Tableau, Alteryx).
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