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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.
· 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
Novanta is proud to be an equal employment opportunity and affirmative action workplace. We consider all qualified applicants without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, military and veteran status, disability, genetics, or any other category protected by federal law or Novanta policy.
Please call +1 781-266-5700 if you need a disability accommodation for any part of the employment process.