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About the Role
Lead the local Design Assurance team in Berlin as a first-line supervisor, while actively contributing as a Design Assurance Engineer to ensure product quality and regulatory compliance for medical devices.
Responsibilities
- 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.
- 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.
- Act as a member of the risk management team, ensuring completeness and consistency of risk analyses.
- Evaluate risk control measures, including impact on severity and probability.
- Ensure availability of evidence for implementation and effectiveness of measures.
- Contribute to Product / Design FMEA activities.
- Support the creation of test specifications for series testing.
- 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.
- Ensure strict adherence to quality requirements, occupational safety regulations, and environmental regulations.
- Follow and implement instructions from Quality and Environmental Management and Occupational Safety functions.
Requirements
- 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.
- 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.
- 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.
- Fluent in English (minimum B2 level).
- Willingness to travel (approx. 10%).
Skills
- Design Assurance
- Product Quality
- Regulatory Compliance
- Medical Device Development
- Quality Plans
- Verification and Validation
- Design Control
- Risk Management (ISO 14971)
- FMEA
- Test Specifications
- Calibration
- Failure Analysis
- Process Improvement
- NC/CAPA
- ISO 13485
- GLP
- GDP
- FDA 21 CFR 820
- Team Leadership
- Communication
- Problem-Solving
Location
- Berlin
Work Type
- Full-time
Experience Level
- 5 years professional experience
- Team leadership experience
Education Level
- Degree in Engineering, Physics, or a related technical field
About the Company
- Novanta's innovations power technology products transforming healthcare and advanced manufacturing.
- We create engineered components and sub-systems for mission-critical applications.
- Novanta operates globally with over 26 offices in The Americas, Europe, and Asia-Pacific.
- We foster a culture that embraces teamwork, collaboration, and empowerment.
Equal Opportunity
- 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.