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.
Your Responsibilities
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.
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
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
Your profile
Your
Education &
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
Additional
Fluent in English (minimum B2 level)
Willingness to travel (approx. 10%
We offer
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