(Senior) Systems Engineer Disposables (m/f/d)

Novanta; Berlin; Vor Ort; EUR 50.000 - 90.000; Vollzeit

Zusammenfassung

Join a forward-thinking company that is revolutionizing healthcare technology. This role focuses on the technical implementation of medical accessories, ensuring compliance with stringent design guidelines. You will collaborate with various teams to define system designs, manage product features, and oversee technical documentation. If you are passionate about enhancing patient outcomes through innovative solutions and have a strong background in systems engineering, this is the perfect opportunity for you. Embrace a culture of teamwork and empowerment while contributing to life-changing technologies.

Qualifikationen

• Several years of experience in developing medical device products.
• Good knowledge in mechanics, sterility, and biocompatibility.

Aufgaben

• Define and document system design based on architecture and requirements.
• Coordinate technical solutions and manage project components.

Kenntnisse

Systems Engineering

Requirement Management

Mechanical Knowledge

Biocompatibility Knowledge

Design to Cost

Manufacturing Processes Knowledge

Technical Documentation

Risk Management

English Proficiency

German Proficiency

Ausbildung

Dipl.-Ing./Master of Electrical Engineering

Master of Medical Technology

Master of Mechanical Engineering

Master of Materials Engineering

Master of Biology

Tools

SAP

Jobbeschreibung

Build a career powered by innovations that matter! At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing—improving productivity, enhancing people’s lives and redefining what’s possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications—from minimally invasive surgery to robotics to 3D metal printing.

Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific. Looking for a great place to work? You have found it with a culture that embraces teamwork, collaboration and empowerment. Come explore Novanta.

This position is part of Novanta’s Advanced Surgery business unit group. Novanta offers highly reliable, precise and safe solutions that enhance system performance and improve patient outcomes. Insufflators, pumps and disposable tube sets, along with medical visualization and operating room integration technologies are the preferred solution for minimally invasive surgery applications.

Summary

This job is responsible for the technical implementation of products based on defined architecture and master specifications in accordance with company-wide design control guidelines. The development focus of this position is on medical accessories, e.g. tube sets for insufflators and pumps.

Primary Responsibilities

• Definition and documentation of the system design on the basis of the given architecture and platform development, taking into account regulatory and normative provisions.
• Analysis of external/internal stakeholder requirements.
• Pre-selection and assignment of customer requirements to existing solutions of the platform, coordination with stakeholders if necessary.
• Determination 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 support of the associated work packages (target definition, DoD) together with the project manager and the departments.
• Preparation 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 the equipment and hose set constructions (Alpha, Beta, Vali).
• 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 tube sets.
• Support of manufacturing processes up to pilot series (NPI); Technical support of production (PE).
• Control of material and BOM creation/management.
• Preparation and maintenance of 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).

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

Education:

• Dipl.-Ing./Master of Electrical Engineering/ Medical Technology/ Mechanical Engineering or Materials Engineering/ Biology or equivalent.

Technical Requirements:

• Several years of experience in the development of disposables or medical device products in the role of Systems Engineer.
• Good knowledge in the fields of mechanics, sterility, biocompatibility.
• Experience in Design to Cost.
• Good knowledge of manufacturing processes of sterile tubing sets (gluing, welding, packaging, etc.).
• Experience in defining requirements or requirement management systems.
• Knowledge of verification procedures.
• Experience in transferring products to production.
• Very good English is required, German would be a plus.
• Knowledge of SAP desirable.

Travel Requirements

• Willingness to travel to all locations and business contacts.