System Engineer

Pracovní nabídka

Summary

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

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

• 1+ years of mfg. support experience in medical manufacturing and/or quality
• Understanding regulatory standards
• 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

What we can offer

• International environment with opportunities for growth
• Stable company in the Medical Devices industry
• Possibility of home office and flexible working hours
• 25 days of vacation
• Free lunches
• Contribution to pension savings
• Commuting allowance
• Edenred card
• Other company benefits