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Lead Test Engineer

Employer
Natus Medical Incorporated
Location
Middleton
Salary
Competitive

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The Lead Test Engineer will be responsible for leading a global test engineering team in charge of creating and executing test protocols. You could expect to provide test expertise and support to design engineers to ensure adequacy and testability of product requirements. The right candidate will possess a strong background in medical device design and verification testing and has a track record of solving complex test related challenges.

Main Responsibilities

Leads test engineers in global projects to ensure consistent approach of similar test challenges
Work in a lead tester role for remediation programs involving cross-functional team members
Ensures traceability between design inputs and verification is accurate and adequate
Owns test tool and method validations
Responsible for resource planning and logistics for verification execution
Participate in or lead technical design reviews, quality improvements, issue investigations
Takes responsibility for the quality of design history files and adherence to quality management system and design controls processes
Provides hands-on support to test team in meeting program deliverables and quality goals
Provide guidance and training to other engineering team members
Applies ISO 13485, ISO 14971, US FDA Quality System Regulations (21 CFR 820), EU MDR and relevant international standards to design activities
Reviews design verification plans, protocols, and reports and review results for accuracy and traceability
Coordinates with both Natus internal and offshore R&D team members for execution
Travel: up to 25% domestic or international travel

Qualifications

Bachelor's degree in Engineering or Science; Master's degree is preferred
Minimum seven years' experience with testing and product development in the medical device industry
Hands on experience in testing required; hardware testing experience highly preferred
Medical device remediation experience applying applicable regulations, quality, and safety standards is required
Experience leading global teams is required
Knowledge and experience with systems engineering
Experience with requirements specification and traceability
Demonstrated ability to deal with a fast-paced environment, high levels of ambiguity, multiple concurrent projects, and conflicting priorities
Demonstrated initiative, attention to detail, customer focus, and commitment to ongoing process improvement
Knowledge of product lifecycle management
Ability to communicate technical knowledge in a clear and understandable manner
Experience with project management preferred, but not required
Experience with JAMA or other requirements management tool preferred, but not required

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