Job: Mechanical – Manufacturing Engineer, Titan Medical, Inc., Chapel Hill, NC
Mechanical – Manufacturing Engineer
Chapel Hill, NC 27517 United States
Titan Medical Inc. is a Canadian public company headquartered in Toronto, Ontario with it’s Research & Development center in Chapel Hill, North Carolina. Titan is focused on the design, development and commercialization of new robotic surgical technologies.
We are seeking a highly motivated candidate to join our Research & Development department.
This position possesses a strong grasp of manufacturing and V&V processes and is accountable for managing the design for manufacture and transfer to manufacturing of Titan Medical’s surgical robotic system. This individual will define test methods, establish manufacturing/assembly lines, and take devices through Verification and Validation.
Responsibilities and Duties:
• Translate Company needs into engineering requirements.
• Design, build, and validate new and existing products.
• Design, build, and validate assembly/test fixtures for production of new and existing products.
• Perform safety risk analysis to assure the safety and efficacy of the device.
• Perform technical/functional risk analysis to uncover engineering and project risks.
• Write verification and validation plans and protocols to effectively test designs against requirements and customer needs.
• Perform or oversee the execution of verification and validation testing.
• Review test data against established pass criteria.
• Write clear, data-driven technical summaries and test reports.
• Manage and maintain device drawing package and BOM.
• Support research initiatives.
Manufacturing Responsibilities and Duties:
• Transfer designs to qualified manufacturing partner to ensure high quality and efficient manufacture of products and packaging.
• Ensure appropriate selection and qualification of vendors and contract service providers.
• Develop protocols, procedures, and reports necessary for comprehensive validation, and manage process validation for manufactured product and associated assembly equipment, test equipment, and processes at manufacturing partners.
• Provide technical oversight and support to sustain production of products manufactured at remote locations including the resolution of 1st and 2nd tier supplier issues.
• Evaluate engineering change requests to determine impacts on design and process and that they are suitable and practical for manufacturing.
• Identify opportunities for cost reduction. Implement process and product improvements to achieve cost reduction goals.
• Support use of robotic surgical system in preclinical and clinical environments.
• Provide technical support/consulting to Titan Medical staff and contract development and manufacturing entities.
• Identify and resolve quality issues.
• Support development and maintenance of Quality System consistent with the QSR and ISO 13485.
• Support regulatory filings.
• Perform other duties as assigned
• Bachelor of Science degree in mechanical, electrical, or biomedical engineering.
• 10 years of engineering experience including design and manufacturing.
• Prior medical device experience is required.
• Familiarity with manufacturing processes is required.
• SolidWorks software experience is required.
• Robotics experience is desirable.
• Self-motivated, proactive, and independent, with strong organizational skills to handle shifting priorities, multiple projects/tasks with minimal supervision.
• Demonstrates logical thinking with exceptional problem solving skills.
• Strong computing skills including MS Office Suite, MS Project or equivalent.
• Good organizational, planning and time management skills.
• Able to travel 10%-20% for manufacturing audits and to support clinical trial sites if needed.
Work Environment and Physical Demands:
• Duties will be split between office environment, laboratory, and manufacturing facilities.
• Overtime may be necessary as workloads dictate. This may include weekdays, weekends and/or holidays to meet project deadlines.
• Travel will be required outside of the area to varying locations and environments with little notice.
• Able to move and lift equipment and supplies up to 70 pounds without mechanical aid.
• Standing or sitting for long periods may be required.
• Ability to see computer terminal and electronic displays on devices (with or without prescription glasses).
Titan Medical is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
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