Senior Manufacturing Engineer
- Fremont, CA
Think Surgical Inc,. is a pioneer in medical robotics and world leader in image-directed, robotic products for orthopedic applications. The company’s product allows surgeons to plan their surgery using 3-D representation of each patient’s CT images, and then execute the surgical plan in the operating room, exactly as planned.
The Manufacturing Engineer is an experienced person within the medical device industry with extensive knowledge performing their function with the Food & Drug Administration (FDA) Quality System Regulations (QSRs), International Organization of Standardization (ISO) 13485, Medical Device Directive (MDD) 93/42/EEC, and ISO 14971. The position entails working closely with design engineers, manufacturing personnel, and the quality department to support the manufacturing of current and next generation surgical systems. General responsibilities include managing production personnel, completing and managing deliverables in the areas of manufacturing, packaging, graphics, and production tolling associated with the development, and commercialization of the TSolution One surgical systems.
This position may require less than 5% travel.
· Work closely in the Product Development team to translate device designs into manufacturing specifications using design output documents.
· Involve in a variety of development projects including design, fabrication, and processing.
· Develop test procedures and testing modules for manufacturing validations.
· Troubleshooting, fabricating, and repairing machines, mechanical assemblies, and related CAD drawings.
· Perform both product and process failure investigations.
· Develop test protocols for failure investigation on products or components, as required.
· Develop and maintain the documentation necessary to ensure the consistent manufacturing of products (processes, drawings, etc.)
· Develop, propose and implement projects to reduce costs and improve quality.
· Design and evaluate new and existing fixtures and equipment, test methods, specifications, layouts, and standards supporting a manufacturing environment.
· Direct support of daily manufacturing production as the operations technical expert from line start up through product transfer to production.
· Responsible for the development and maintenance of PFMEA.
· Identify and recommend manufacturing technologies to strategically develop business objectives and potential opportunities.
· Train technicians on assembly methods, equipment, and procedures for new and existing products.
· Review DCO’s that impact manufacturing processes used in production.
· Participate on project teams to support new process/product development and the successful transfer of product into manufacturing.
· Comply with applicable FDA and international regulatory laws/standards.
· Adhere to and enforce the company code of conduct, policies and practices in the production floor.
· Other duties or special projects as required in order to meeting company’s objectives.
· 8+ year experience in manufacturing and process engineering in the medical device industry.
· Four-year, accredited degree in Engineering.
· Able to read, evaluate, and draft mechanical drawings; understand technical product specifications
· Familiar with basic mechanical tools and their use in fabrication, measurement and assembly.
· Familiar with current mechanical design, analysis, verification and validation techniques.
· Must have effective verbal and written communication skills, including the use of MS Word and Excel.
· Experience with 3D modeling software, math software, and CAM software.
· Knowledge of statistical and analytical methods such as SPC, SQC, and DOE.
· Knowledge of electrical workmanship standards: IPC 610E, ANSI ESDS 20:20
· Experience with medical instrument development (FDA design controls and ISO standards)
· Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
· Attendance and Punctuality are essential function of the position.
Think Surgical Inc,. offers a fast-paced work environment, very competitive compensation, medical and 401K retirement plan benefits.
We are an equal opportunity employer and encourage diversity.