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Skills: Team Leadership, Design Assurance, Risk Management, ISO 14971, ISO 13485
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Full-time
bachelor degree
Posted 15d ago
~40 hrs/week
Responsibilities
Lead the local Design Assurance team in Berlin while actively contributing as an engineer to ensure product quality and regulatory compliance for medical devices. Responsibilities include creating quality plans, managing risk assessments, and overseeing verification and validation activities.
Requirements
Requires a degree in Engineering, Physics, or a related field with at least 5 years of experience in a regulated industry. Candidates must be fluent in English and possess strong knowledge of ISO 13485 and medical device quality standards.
Full 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 +1 781-266-5700 if you need a disability accommodation for any part of the employment process.
Novanta is a leading global supplier of core technology solutions that give medical, life science, and advanced industrial original equipment manufacturers a competitive advantage. We combine deep proprietary expertise and competencies in precision medicine, precision manufacturing, robotics and automation, and advanced surgery with a proven ability to solve complex technical challenges. This enables Novanta to engineer proprietary technology solutions that deliver extreme precision and performance, tailored to our customers' demanding applications. The driving force behind our growth is the team of innovative professionals who share a commitment to innovation, the Novanta Growth System, and our customers’ success. Novanta’s common shares are quoted on Nasdaq under the ticker symbol “NOVT.”
Offices: 125 Middlesex Turnpike,, Bedford, Massachusetts 01730, US · 7279 William Barry Boulevard, North Syracuse, New York 13212, US · 100 Paramount Dr, Suite 101, Sarasota, Florida 34232, US · 4600 Campus Place, Mukilteo, Washington 98275, US · 3900 Atherton Rd, Rocklin, California 95765, US
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