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Global Systems Engineering Manager - Medical Device
at Natus Medical
USA, Wisconsin, Middleton
Regular Full time
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 Global Systems Engineering Manager leads the Systems design functional disciplines (projects, processes, and people) within the R&D organization for the entire organization’s product lines of Neurology, Newborn Care, and Audiology. As a functional leader, the Manager will supervise and coordinate the activities of all levels of Systems Engineers, Requirement Engineers, and Risk Managers (domestically and internationally located). The Manager provides hands-on leadership, assesses and develops talent, and ensures projects are staffed appropriately. This position may be based out of our Middleton, WI; Schaumberg, IL; or San Diego, CA sites.
In this job, you will:
- Ensure that all direct reports are familiar with, trained on and follow all Quality System procedures related to their jobs which can affect the quality of products or services provided to our customers and that changes to procedures are reviewed, approved and validated prior to implementation
- Provide technical and functional leadership to the Systems design team distributed globally at various design centers
- Collaborate with cross-functional stake holders such as R&D, Marketing, QA/RA, Service, Manufacturing, PMO to ensure alignment on project scope, design control documentation, quality and schedule
- Ensure the system team deliverables are of high quality and that they adhere to Natus QMS design controls. Own and Drive requirements engineering, human factors engineering, Risk Management and Product Compliance
- Provide gap assessment on products against the latest and or new regulations such as IEC 60601, IEC 62304, ISO 10993, ISO 11137, EU and FDA regulations and guidances
- Support the Regulatory team with Product Registrations in International geographies including China, Japan, Korea and Brazil
- Create key performance and indicators (KPI) , process and product quality metrics to assess the success of projects; use KPIs to make continuous process improvements
- Review and approve system level documentation including Requirements, Risk Analysis, Risk Management Report, Usability file. Participate in systems, hardware and cross-functional technical reviews
- Hold task owners accountable for delivering on time and with high quality. Identify project risks proactively and countermeasures to mitigate the risks
- Travel: Moderate
- Supervisory Responsibilities: Directly supervises employees located globally. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring and training employees; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Bachelor’s Degree in Engineering discipline or equivalent; Master’s degree in an Engineering discipline preferred.
- 7+ years’ experience of successfully demonstrated experience in leading Systems, Hardware or Software Development function within medical device/diagnostics industry
- Minimum 3 years leadership experience with direct management responsibilities for direct reports required; experience managing people globally
- Experience leading product development from requirements to final release/launch
- Extensive experience working with global teams and offshore partners
- 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
- Demonstrated strong sense of urgency and ability to manage conflicts
- Ability to work with with JAMA, MS Project, MS Excel, Time tracking tools
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 to start) and tuition reimbursement.
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.