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Global Mechanical Design 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 Mechanical Design Engineering Manager leads the product mechanical 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 diagnostics areas. As a functional leader, the Manager will supervise and coordinate the activities of all levels of Mechanical Design Engineers and Optical Design Engineers (located domestically and internationally). The Manager provides hands-on leadership, assesses and develops talent, and ensures projects are staffed appropriately. This position may be based out of Middleton, WI; Schaumberg, Il; or San Diego, CA sites.
In this job, you will:
- Ensures 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 mechanical design and development team distributed globally at various design centers
- Bring industry best practices of Mechanical Development, and help navigate changing technologies and trends
- Collaborate with cross-functional stake holders such as Marketing, QA/RA, Service, Manufacturing, PMO to ensure alignment on project scope, design control documentation, quality and schedule
- Ensure the mechanical design deliverables are of high quality and that they adhere to Natus QMS design controls. Own and Drive mechanical design requirements, mechanical design and development and DMR including the product BOM
- 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 technical documents in architecture, design, assembly instructions etc. Participate in systems, hardware and cross-functional technical reviews
- Establish and modernize the engineering process and tools that are used by the team to optimize engineering performance in the context of business needs
- 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 Mechanical Engineering, Materials Engineering, Biomedical Engineering or equivalent; Master’s degree preferred, or ten years related experience and/or training; or equivalent combination of education and experience.
- 7+ years’ experience of successful demonstrated experience in leading Mechanical or opto-mechanical design and 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 in Solidworks
- Experience leading product development from requirements to final release/launch
- Extensive experience working with global teams and offshore partners; Experience managing people globally
- Extensive experience in designing and detailing injection molding parts, machined parts and opto-mechanical designs
- 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-60601
- Demonstrated strong sense of urgency and ability to manage conflicts
- Ability to work with with 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.