Systems Engineer Medical Devices

Stellenbeschreibung:

Novanta’s Advanced Surgery business unit specializes in Minimally Invasive Medicine, developing devices that enable surgeons to perform operations with small incisions. The unit produces cameras, insufflators, medical pumps, and tubing that simplify diagnosis and treatment, turning complex surgeries into minor procedures.

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, coordinating with stakeholders if necessary.
Determination of features to be integrated, creating feature requests when required.
Technical implementation of new product features, preferably as reusable platform components.
Creation of product‑specific system specifications.
Coordination of technical solutions between individual departments.
Technical management of project components and content‑related support of associated work packages (target definition, Definition of Done) together with the project manager and specialist departments.
Creation and maintenance of technical documentation together with the project manager.
Product‑specific risk management in cooperation with the risk manager.
Product‑specific verification plans and their successful implementation.
Technical management of equipment and hose set construction (Alpha, Beta, Vali).
Design transfer of products into production.
Review and approval of assembly instructions.
Standard testing of 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.
Technical release of the products by the customer.
Technical contact person for customers (e.g., project acquisition), suppliers, external development partners and internal departments.

Required Experience, Education, Skills, Training and Competencies

Dipl.-Ing./Master in Electrical Engineering, Medical Engineering, Mechanical Engineering, Materials Engineering, Biology or equivalent (MSc preferred).
Several years of product development experience as a 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 team player, experience working in 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‑oriented way of working.