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Design Assurance Engineer / Medical Devices (m/f/d)

Novanta -
Berlin

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Details zur Stelle

Vollzeit

Vollständige Stellenbeschreibung

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. 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.

As Design Assurance Engineer you are responsible for creation of an overall quality plan, review of design verification and validation specifications, test specifications and reports for medical devices (devices and consumables), review of Design Control documents according to GDP, MDR 2017/CFR820 and leading/contributing to risk management, FMEA and other quality (assurance) related tasks within product development.

Primary Responsibilities

Within the framework of design control:

Support on creation of overall superior quality plan including document plan and overall VnV plan
Review of design verification and validation test specification for medical devices (equipment and consumables)
Review of design control documents according to GLP, GDP, CFR820
Member of the product and design FMEA team

As a member of the risk management team according to ISO 14971:

Contribute to the content of the risk management throughout the product development
Review of the systematics and completeness of the risk analysis
Evaluation of risk-reducing measures regarding impact on severity of damage and probability of occurrence
Creation and review of the evidence for implementation and effectiveness of the measures

In cooperation with Quality Assurance and Production:

Involvement in the preparation of test specifications and test requirements for the series testing of medical devices

Other tasks:

Active participation in measures for synchronization and improvement of processes
Failure analysis for field returns and during development
Strict compliance with quality, occupational safety and environmental regulations and implementation of instructions by quality/environmental officers and the specialist for occupational safety

Required Experience, Education, Skills and Competencies

Completed technical and/or physical studies
At least 2 years of professional experience
Experience with product quality in a highly regulated industry (medical device, automotive, aviation etc.)
Experience in theory and application of quality methods and techniques
English fluency, Germany would be plus
Quality-conscious, trustworthy and reliable
Team player
Good communication skills
Structured and systematic way of working

Travel Requirements

Willingness to travel to all locations and business contacts (10%)

Novanta offers a package of services that includes health and financial services.

#LI-JM1

#Berlin

#Hybrid

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.

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Erweiterte Suche

and development officer Jobs in berlin, be

Design Assurance Engineer / Medical Devices (m/f/d)

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Armed Security Officers (f/m/d) (19,30€ / h)

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Associate to the CEO (Werkstudent) (m/f/d)

Executive Director Client Production Solutions & Growth (Publicis Production)

Technischer SHK Experte (m/w/d) Entwicklung & Laborleitung

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