Systems Engineer Medical Devices (m/f/d)

This position is part of Novanta’s Advanced Surgery business unit. Specialized in the field of Minimally Invasive Medicine, WOM develops devices and accessories so that doctors can operate with small cuts. We produce Cameras, Insufflators, Medical Pumps, and tubing that makes diagnosis and treatment easier for everyone. Our insufflators and pump systems dilate cavities in the body and turn previously complicated surgeries into minor procedures. Together with customers, doctors, and technical experts, our teams continuously search for new ways to innovate. 

Summary 

Responsible for the technical realization of products based on defined architecture and master specifications in accordance with company-wide design guidelines 

Primary Responsibilities 

• Definition and documentation of the system design based on the specified architecture and platform development, taking into account regulatory and normative provisions 

• Analysis of external/internal stakeholder requirements 

• Pre-selection and allocation of customer requirements to existing solutions of the platform, if necessary coordination with stakeholders 

• Determination of the features to be integrated, if necessary creation of a feature request 

• Responsibility for the technical implementation of new product features, preferably as a reusable component of the platform 

• Creating product-specific system specifications 

• Coordination of technical solutions between the individual departments 

• Technical management of the technical project components and content-related support of the associated work packages (target definition, DoD) together with the project manager and the specialist departments 

• Creation and maintenance of technical documentation together with the project manager 

• Responsible for product-specific risk management in cooperation with the risk manager 

• Responsible for the product-specific verification plans and their successful implementation 

• Technical management of equipment and hose set construction (Alpha, Beta, Vali) 

• Transfer (design transfer) of products into production 

• Responsible for the review and approval of assembly instructions 

• Responsible for standard testing of the device and hose sets 

• Support of manufacturing processes up to the pilot series (NPI); Technical support of production (PE) 

• Control of material and parts list creation/management 

• Creation and maintenance of technical documentation together with the project manager 

• Responsible for the technical release of the products by the customer 

• Technical contact person for customers (e.g. project acquisition), suppliers, external development partners and internal departments 

• Evaluation of applicants / participation in interviews 

• Support for students 

• Participation in the assessment of the impact of changes in standards on the area 

General Tasks 

• Intensive collaboration within the development department and company-wide 

• Participation in the development of company standards and their application 

• Initiation and active participation in measures for synchronization processes 

• Active participation in the innovation process 

• Strict compliance with quality, occupational safety and environmental regulations and implementation of instructions from quality/environmental management representatives and the occupational safety specialist 

Required Experience, Education, Skills, Training and Competencies

• Dipl.-Ing./Master Electrical Engineering/ Medical Engineering/ Mechanical Engineering or Materials Engineering/ Biology or equivalent (MSc preferred)
• Several years of product development experience in the role of systems engineer for Medical Devices
• Good knowledge of systems development and/or software design
• Good knowledge of embedded systems, hardware, software and mechanics
• Experience in defining requirements or requirement management systems
• Great communication skills
• Collaborative mindset and a team player, experience in working with an international environment  
• Experience in design to cost
• Knowledge of verification procedures
• Experience in transferring products into production
• Knowledge of relevant norms and standards (e.g. ISO 13485)
• Professional Working Proficiency in English (C1)
• Quality-conscious, trustworthy and reliable
• Willingness to travel to all locations and business contacts
• Structured, systematic and solution-orientated way of working

Preferred qualifications

• knowledge of Polarion and SAP software
• knowledge of agile methodology and MS Azure tool
• Knowledge of cyber security measures and standards 

Travel Requirements  

• Yes up to 10-20%  
   

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