Supervisor Design Assurance (m/f/d)

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.

As our new Supervisor Design Assurance Engineers (m/f/d), you lead the local Design Assurance team in Berlin as first-line supervisor.

In addition to your leadership responsibilities, you actively contribute as a Design Assurance Engineer, ensuring product quality and regulatory compliance throughout the development of medical devices (devices and consumables). This includes creating quality plans, reviewing verification and validation activities, ensuring compliance with Design Control requirements, and contributing to risk management and FMEA activities.

Your Responsibilities

Team Leadership

• Provide first-level leadership to the local Design Assurance team in Berlin

• Coordinate and supervise daily activities and priorities

• Ensure tasks are completed efficiently and in line with defined processes

• Support, motivate, and develop team members to build and maintain an engaged and high-performing team

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Design Assurance & Development Support

• Create overall quality plans, including document plans and V&V strategies

• Create and review design verification and validation plans for medical devices

• Review Design Control documentation in compliance with GLP, GDP, and FDA 21 CFR 820

Risk Management (ISO 14971)

• Act as a member of the risk management team

• Ensure:

• Completeness and consistency of risk analyses

• Evaluation of risk control measures, including impact on severity and probability

• Availability of evidence for implementation and effectiveness of measures

Product Development & Quality Activities

• Contribute to Product / Design FMEA activities

• Support the creation of test specifications for series testing in cooperation with Quality Assurance

• Manage, maintain, and adjust calibration of measuring equipment

• Perform failure analysis of non-conforming units

• Initiate and actively support process improvements and harmonization activities

• Support and perform NC/CAPA activities in accordance with ISO 13485

Compliance & Standards

• Ensure strict adherence to:

• Quality requirements

• Occupational safety regulations

• Environmental regulations

• Follow and implement instructions from Quality and Environmental Management and Occupational Safety functions

Your Profile

Education & Experience

• Degree in Engineering, Physics, or a related technical field

• 5 years of professional experience in a regulated industry

• Prior team leadership experience is an advantage

Professional Skills

• Experience in product quality within highly regulated industries (medical devices preferred; automotive or aviation accepted)

• Knowledge of ISO 13485 and quality management systems

• Experience with quality and statistical methods

• Experience in system, reliability, software, or hardware testing

Personal Competencies

• Strong ability to lead, motivate, and develop teams

• Ability to coordinate tasks and assess team capabilities effectively

• Clear and professional communication across all organizational levels

• Structured, systematic, and quality-focused working style

• High level of reliability and integrity

Additional Requirements

• Fluent in English (minimum B2 level)

• Willingness to travel (approx. 10%)

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.