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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 realisation 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 on the basis of 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 platform solutions, coordination with stakeholders if necessary
- Definition of the features to be integrated, creation of a feature request if necessary
- Responsibility for the technical implementation of new product features, preferably as a reusable component of the platform
- Creation of product-specific system specifications
- Coordination of technical solutions between the individual departments
- Technical management of the technical project components and content-related support for the associated work packages (target definition, DoD) together with the project manager and the specialist departments
- Creation and maintenance of the technical documentation together with the project manager
- Responsible for product-specific risk management in collaboration with the risk manager
- Responsible for the product-specific verification plans and their successful implementation
- Technical management of the device and hose set constructions (Alpha, Beta, Vali) Transfer (design transfer) of the products to production Responsible for the review and approval of assembly instructions Transfer (design transfer) of the products to production
- Responsible for the review and approval of assembly instructions
- Responsible for the standard tests of the device and hose set
- Support of the production processes up to the pilot series (NPI); technical support of production (PE)
- Control of material and parts list creation/management
- Creation and maintenance of the technical documentation together with the project manager
- Responsible for the technical approval of the products by the customer
- Technical contact person for customers (e.g. project acquisition), suppliers, external development partners and internal departments
- Management and organisation of department-specific training
- Assessment of applicants / participation in interviews
- Supervision of students
- Assessment of the impact of changes in standards on the field
- Mentoring
General Tasks
- Intensive cooperation within the development department and company-wide
- Active participation in the development of company standards and application of these
- Initiation and active participation in measures for synchronisation processes, further development of processes in the area
- Active participation in the innovation process
- Strict compliance with quality, occupational safety and environmental regulations and implementation of instructions
- from quality/environmental management officers 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
- 5+ years of relevant work experience required. Preferably in the development of medical device or disposable products
- Proven track record of successful development of medical devices (Class II) in the role of Systems Engineer.
- For Device Systems Engineer:
- Very good knowledge of system development and/or software design
- Very good knowledge of embedded systems, software, mechanics and hardware
- For Tubing Set Systems Engineer:
- Very good knowledge of mechanics, sterility, biocompatibility
- Very good experience in design to cost
- Very good knowledge of manufacturing processes of sterile tubing sets (bonding, welding, packaging, etc.)
- Expertise in defining requirements or requirements management systems
- Experience in verification procedures
- Experience in Design to Cost
- Experience in the transfer of sterile tubing sets to the medical device industry
- Experience in transferring medical devices to production
- Knowledge of verification procedures
- Knowledge of the relevant norms and standards as well as the approval process (FDA; CE)
- Good knowledge of English (GER-B2)*
- SAP knowledge desirable
- Quality-conscious, trustworthy and reliable
- Willingness to travel to all locations and business contacts
- Team player
- Very good communication skills
- Structured, systematic and solution-orientated way of working
Travel Requirements
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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.