System Engineer

About the role

Responsible for SME validation, SME technical/process operative and supporting Project Manager PE, Manufacturing Engineering, in strategic and operative tasks. Primary Responsibilities - Evaluation and documentation of product changes based on the system architecture, considering existing specifications, risk management, regulatory and standards - Development of test and verification plans for product changes and validations based on technical evaluation - Review of risk management in the context of product changes. - Monitoring the technical progress of product change projects. - Responsibility for planning and/ or execution of product tests. - Creation and maintenance of technical documentation in area of responsibility. - Collaborate with the quality department to ensure adherence to product standards and regulatory compliance. - Actively learn and deploy NGS (Novanta Growth System) initiatives and lead adoption of NGS principles in the area. General Tasks - Preparation and review of verification/ validation plans/reports. - Conduct validations, tests and data analysis. - Preparation and review of technical documentation and standard operating procedures. - Participate in team meetings, brainstorming sessions, and cross-functional projects. - Development of test methods - Responsible for order and organization of the test rooms and laboratories Required Experience, Education, Skills, Training and Competencies - Bachelor's degree in Engineering (prefer Mechanical or Manufacturing) - 1+ years of mfg. support experience in medical manufacturing and/or quality - Understanding of medical device production and regulatory standards (ISO 13485, ISO 14791) - English B2 level (spoken, written communication on daily basis) - Understanding of statistical tools and associated analytic tools - Experience with Problems Solving tools (ex: FMEA, 8D, Six Sigma) - MS Office (Excel, Word, Powerpoint) - SAP knowledge (or similar ERP system) is a plus - Detail-oriented with a strong commitment to quality and accuracy - Knowledge of medical materials usage and requirements is a plus - Self-motivated - Able to work independently and as part of a team. Good Communication Skills Travel Requirements - 10-20%. Occasional visits to other Novanta facilities

Benefits

Additional Information

Build a career powered by innovations that matter! At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing-improving productivity, enhancing people's lives and redefining what's possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications-from minimally invasive surgery to robotics to 3D metal printing. Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific. Looking for a great place to work? You have found it with a culture that embraces teamwork, collaboration and empowerment. Come explore Novanta.

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