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

Novanta Inc.; Berlin; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

Novanta Inc. seeks a '(Senior) Systems Engineer Disposables' in Berlin to manage and implement technical solutions for medical device products. Responsibilities include system design documentation, stakeholder coordination, and regulatory compliance, requiring in-depth knowledge in mechanics and biocompatibility. Ideal candidates will possess a Master's degree in relevant engineering fields and several years of experience in medical product development.

Qualifikationen

• Several years of experience in development of disposables or medical devices as Systems Engineer.
• Willingness to travel to all locations and business contacts.
• Experience in transferring products to production.

Aufgaben

• Define and document system design based on architecture.
• Analyze stakeholder requirements and assign them to solutions.
• Ensure compliance with quality and safety regulations.

Kenntnisse

Mechanical knowledge

Knowledge of sterility

Experience in Design to Cost

Good knowledge in biocompatibility

Verification procedures knowledge

SAP knowledge

English fluency

German knowledge

Ausbildung

Dipl.-Ing./Master of Electrical Engineering

Master of Medical Technology

Master of Mechanical Engineering

Materials Engineering/ Biology or equivalent

Jobbeschreibung

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

Apply locations Berlin, Germany time type Full time posted on Posted 30+ Days Ago job requisition id R007826

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.

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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 [phone] if you need a disability accommodation for any part of the employment process.

About Us

Solving complex challenges, delivering innovations that matter!
Novanta is a leading global supplier of core technology solutions that give medical, life science, and advanced industrial original equipment manufacturers a competitive advantage. We combine deep proprietary expertise and competencies in precision medicine, precision manufacturing, robotics and automation, and advanced surgery with a proven ability to solve complex technical challenges. This enables Novanta to engineer proprietary technology solutions that deliver extreme precision and performance, tailored to our customers' demanding applications. The driving force behind our growth is the team of innovative professionals who share a commitment to innovation, the Novanta Growth System, and our customers’ success. Novanta’s common shares are quoted on Nasdaq under the ticker symbol "NOVT".