Supervisor Design Assurance (m/f/d)

Reposted 2 Days Ago
Be an Early Applicant
Berlin, DEU
In-Office
Senior level
Appliances • Industrial • Manufacturing
The Role
Lead the local Design Assurance team and perform hands-on design assurance for medical devices: create quality and V&V plans, review design control documentation, support risk management (ISO 14971) and FMEA, manage calibration and failure analysis, and drive NC/CAPA and process improvements to ensure regulatory compliance and product quality.
Summary Generated by Built In

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

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.

Skills Required

  • Degree in Engineering, Physics, or related technical field
  • 5 years of professional experience in a regulated industry
  • Experience in product quality within highly regulated industries (medical devices preferred; automotive or aviation accepted)
  • Knowledge of ISO 13485 and quality management systems
  • Knowledge of ISO 14971 (risk management), FMEA, and Design Control practices
  • Familiarity with FDA 21 CFR 820, GLP, and GDP
  • Experience with quality and statistical methods
  • Experience in system, reliability, software, or hardware testing
  • Experience with NC/CAPA activities in accordance with ISO 13485
  • Strong ability to lead, motivate, and develop teams; coordinate tasks effectively
  • Prior team leadership experience
  • Fluent in English (minimum B2 level)
  • Willingness to travel (~10%)

Novanta Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novanta and has not been reviewed or approved by Novanta.

  • Healthcare Strength Coverage is described as comprehensive, including medical, dental, vision, mental-health support, HSA/FSA options, telemedicine, and access to on-site clinics in select locations. Plan details indicate broad healthcare support across core needs.
  • Leave & Time Off Breadth Programs include flexible or unlimited time off for many professional roles and a separate PTO structure for non-exempt roles. Paid parental, family, and medical leave are highlighted as substantial in the U.S.
  • Retirement Support A strong 401(k) match with immediate vesting is emphasized. This structure provides meaningful employer support for long-term savings.

Novanta Insights

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The Company
HQ: Bedford, MA
2,075 Employees

What We Do

Novanta delivers innovations that matter for its medical and advanced industrial OEM customers. If you have a passion for solving complex technical problems that lead to breakthrough performance and that enhance people's lives, come join our growing team. Here is a sample of the many exciting applications we serve: • Innovations that ensure the safety of patients and efficient workflows in hospitals using our novel RFID technology • Innovations in additive manufacturing, also known as 3-D metal printing, using our lightning fast lasers and laser beam steering sub-systems • Innovations in minimally invasive surgery using our highly reliable insufflators, pumps and visualization systems • Innovations in robotics and automation using our precision motors, encoders and drives for superior accuracy • Innovations in smartphone production using our fast, accurate lasers and laser beam steering equipment along with our precision motion systems The driving force behind our growth is the team of talented professionals who share our commitment to our values, and our passion for innovation and for our customers’ success. Novanta has deep expertise in precision medicine and manufacturing, medical solutions, and robotics and automation: Precision Medicine and Manufacturing: • Continuous wave, ultrafast and CO2 lasers, along with laser beam steering components and sub-systems Brands: ARGES, Cambridge Technology, Laser Quantum, Synrad Medical Solutions: Minimally Invasive Surgery: • Insufflators, pumps and disposable tube sets; medical visualization systems, video processing and wireless imaging Brands: NDS, Med X Change, Reach Technology, WOM Detection & Analysis: • RFID readers, machine vision solutions, barcode scanning, light and color measurement Brands: JADAK Robotics and Automation: • Motors, encoders, servo drives, air bearing systems and integrated mechatronic solutions Brands: ATI, Celera Motion (inc. Applimotion, Ingenia, MicroE, Zettlex, Westwind)

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