Systems Engineer Medical Devices MDR

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Business Unit Overview

This position is part of Novanta’s World of Medicine (WOM) 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 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.

Position Details

Summary

The system engineer is responsible for the development of pumps and insufflators.

Within PE MDR re-engineering of legacy devices are to be conducted to ensure that the technical documentations are in accordance to MDR (EU) and Novanta Quality System.

Primary Responsibilities

• Analysis of external and internal customer requirements
• GAP analysis of technical documentation and development documentation
• Creation of medical device concepts
• Creation of system specifications
• Technical control of the technical project components and content-related support of the associated work packages (goal definition, DoD) together with the project manager and the R&D team
• Responsible for meeting all relevant standards and requirements.

Project Related Tasks

• Design, optimization and documentation of the system architecture of medical devices, considering regulatory and normative provisions (mainly for basic and technology developments)
• Creation of system specifications as part of the specifications phase
• Responsible for risk management
• Monitoring technical development progress
• Responsible for standard testing of the device
• Creation and maintenance of technical documentation for your own area of ​​responsibility
• Technical contact for customers and external development partners
• Technical support for sales in project acquisition

General Tasks

• Strict compliance with the quality, occupational safety and environmental regulations.
• Implementation of the instructions of the quality / environmental management representative and the occupational safety specialist.

Required Experience, Education, Skills, Training and Competencies

• Good English skills
• Development experience in medical disposable products
• Knowledge of system development.
• Development experience in a medically regulated environment; masters the relevant regulations
• SAP knowledge preferable

Travel Requirements

• Willingness to travel to all locations and business contacts

Physical Requirements

• Quality-conscious, trustworthy and reliable
• Willingness to travel to all locations and business contacts
• Team player
• Communication skills
• Structured and systematic way of working

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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.