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R&D Director, Test EngineeringCompany Natus Medical Incorporated
Location Middleton, WI 53562
Update 5 Day ago
Location: Middleton, WI USA or Oakville, Canada
Founded in 1989, Natus Medical Incorporated is a leading manufacturer of medical devices and software and a service provider for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. Natus products are used in hospitals, clinics and laboratories worldwide. Our mission is to improve outcomes and patient care in target markets through innovative screening, diagnostic and treatment solutions.
The Director, Test Engineering will lead the verification group and test activities within Research and Development organization in Neurology Strategic Business Unit (SBU). He/She will oversee verification and support validation activities across multiple modalities – EEG, PSG, EMG, IOM, Supplies & Accessories and interact cross-functionally with Quality, Regulatory, Operations, Marketing team members that are located world-wide. This position will be accountable for ensuring high product quality through verification and validation activities that will be in compliance with Quality Management System (QMS).
In this job, you will:
- Lead the Neurology R&D verification and support validation engineering group and deliverables
- Deliver up-to-date Natus QMS design control documentation that are relevant to the projects in scope
- Ensure high quality in products through innovative ways to perform verification and verification activities. Review data from customer complaints, CAPAs, customer workflows in addition to requirements to perform verification and validation testing
- Collaborate with cross-functional stake holders to involve early in user and product requirements phase to understand the risks
- Streamline defect detection, tracking, escalation and resolution process to ensure efficient resolution of any defects found
- Continuously improve verification and validation process to improve cost, schedule and quality. Implement industry best practices
- Create key performance indicators (KPI) to assess the success of projects; Use KPIs to make continuous process improvements
- Build testing automation and infrastructure to ensure delivery of high quality products
- Coach and develop verification and validation engineers; develop strong verification and validation engineering skills in the team
- Bachelor’s Degree in Engineering or technical field. Advanced degree or MBA preferred
- 10+ years’ experience in software/hardware/systems engineering within medical device/diagnostics industry
- Experience leading a test engineering team in medical device/diagnostics industry; Demonstrated experience in successfully implementing process improvements preferred
- Experience leading verification and validation projects in medical device/diagnostics industry using proper design control QMS processes
- Extensive experience working with global teams and offshore partners; Experience managing people
- Deep Knowledge and application of following standards in the work experience -- FDA Quality System Regulations, Design Controls, Current Good Manufacturing Practices, ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366
- Ability to moderately travel (30%) to global sites
- Demonstrated strong sense of urgency and ability to manage conflicts
Natus offers competitive salaries, comprehensive benefit package that starts on your 1st day, 401k match, an employee stock purchase plan, 9 paid holidays, generous paid time off plan (4 weeks) and tuition reimbursement up to $5,000 annually.
Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.