Supervisor Design Assurance (m/f/d)

novanta; Berlin; On-site; EUR 70,000 - 100,000; Full time

Job summary

Novanta in Berlin seeks an experienced Supervisor Design Assurance Engineers to lead the local Design Assurance team and actively contribute as a Design Assurance Engineer in medical device development.

You will ensure quality plans, V&V activities, Design Control documentation, and risk management per ISO 13485 and related standards, while supporting continuous improvements and compliance efforts.

Qualifications

• Degree in Engineering, Physics, or related technical field.
• 5 years of professional experience in a regulated industry.
• Prior team leadership experience is an advantage.

Responsibilities

• Lead the local Design Assurance team in Berlin and supervise daily activities.
• Create and review design verification and validation plans for medical devices.
• Ensure Design Control documentation complies with GLP, GDP, and FDA 21 CFR 820.
• Contribute to risk management activities and ISO 14971 processes.
• Support Product/Design FMEA and calibration/maintenance of measuring equipment.
• Drive process improvements and NC/CAPA activities across quality systems.

Skills

Leadership

Quality Assurance

Regulatory Knowledge

Risk Management

Medical Devices

Education

Engineering degree

Tools

ISO 13485

V&V planning

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.

As our newSupervisor 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 aDesign 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

• Providefirst-level leadershipto the local Design Assurance team in Berlin
• Coordinate and supervisedaily activities and priorities
• Ensure tasks are completedefficiently and in line with defined processes
• Support, motivate, and develop team members to build and maintain anengaged and high-performing team

Design Assurance & Development Support

• Createoverall quality plans, including document plans and V&V strategies
• Create and reviewdesign verification and validation plansfor medical devices
• ReviewDesign Control documentationin compliance with GLP, GDP, and FDA 21 CFR 820

Risk Management (ISO 14971)

• Act as amember 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 toProduct / Design FMEA activities
• Support the creation oftest specifications for series testingin cooperation with Quality Assurance
• Manage, maintain, and adjustcalibration of measuring equipment
• Performfailure analysis of non-conforming units
• Initiate and actively supportprocess improvements and harmonization activities
• Support and performNC/CAPA activities in accordance with ISO 13485

Compliance & Standards

• Ensure strict adherence to:
  • Quality requirements
  • Occupational safety regulations
  • Environmental regulations
• Follow and implement instructions fromQuality and Environmental ManagementandOccupational Safety functions

Your Profile

Education & Experience

• Degree inEngineering, Physics, or a related technical field
• 5 years of professional experiencein a regulated industry
• Priorteam leadership experience is an advantage

Professional Skills

• Experience inproduct quality within highly regulated industries(medical devices preferred; automotive or aviation accepted)
• Knowledge ofISO 13485and quality management systems
• Experience withquality and statistical methods
• Experience insystem, reliability, software, or hardware testing

Personal Competencies

• Strong ability tolead, motivate, and develop teams
• Ability tocoordinate tasks and assess team capabilities effectively
• Clear and professionalcommunication across all organizational levels
• Structured, systematic, and quality-focused working style
• High level ofreliability and integrity

Additional Requirements

• Fluent inEnglish (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 [phone] if you need a disability accommodation for any part of the employment process.