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

novanta; Berlin; Hybrid; EUR 60,000 - 84,000; Full time

Benefits offered by this job

Health insurance

Financial services

Job summary

Novanta in Berlin is seeking a Design Assurance Engineer to lead quality planning and design control for medical devices, including VnV planning and documentation according to GDP, MDR 2017/CFR820.

You will review design verification/validation, contribute to ISO 14971 risk management, prepare test specifications, and support process improvements. English is required; German is a plus. This hybrid Berlin role offers collaboration with global teams.

Qualifications

• 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; German would be a plus.
• Quality-conscious, trustworthy and reliable.
• Team player; good communication skills.
• Structured and systematic way of working.
• Eligible to work legally in Germany.

Responsibilities

• Create and maintain the overall quality plan and VnV plan.
• Review design verification and validation test specs for medical devices (equipment and consumables).
• Review design control documents according to GDP, CFR820.
• Member of the product and design FMEA team.
• Contribute to the content of risk management throughout product development.
• Prepare test specifications and requirements for series testing of medical devices.
• Active participation in measures for synchronization and improvement of processes.

Skills

Quality Assurance

FMEA

Design Control

Risk Management

Regulatory compliance

English fluent

Team player

Education

Technical degree in engineering or related field

Job description

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
• Eligible to work legally in Germany

Travel Requirements

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

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

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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.