Manufacturing Engineer

Position : Manufacturing Process Engineering Location : Belmont, CA Key Responsibilities: · Design & develop components, fixtures, or entire test equipment systems to support the development of novel intraocular lens devices & technologies. · Responsible for conducting experiments, and root cause analysis for emerging manufacturing, or design defects. · Works 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 to meet project milestones & timelines for intraocular lens development. · Develop and execute design validation test protocols and document results in test reports. · Accountable for preparing and presenting study protocols, technical reports, technical presentations, and other supporting documents for internal and external submissions. · Participate in cross-functional manufacturing and R&D activities as a functional representative on various core-team and sub-team project meetings. · Work with suppliers, and contract manufacturers, and 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. Key Qualifications: · Experience in manufacturing · Experience with NCMR, corrective actions and deviations · 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 Preferred Qualifications: · 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 Key Requirements/Minimum Qualifications: · Bachelor’s Degree with two years of experience/master’s degree (Mechanical Engineering, Biomedical Engineering, Chemical Engineering) · The ability to fluently read, write, understand, and communicate in English Travel Requirements: 10% Domestic Job Types: Full-time, Contract Pay: $50.00 - $55.00 per hour Expected hours: 40 per week Education: Bachelor's (Required) Experience: ISO 13485: 1 year (Required) IQ/OQ: 3 years (Required) Medical device: 3 years (Required) Work Location: In person