Manager, Global Mechanical Design Engineering is a management leader who leads the product mechanical design functional disciplines (projects, processes and people) within R&D organization for the entire Natus product lines in Neurology, New born 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. The Manager provides hands-on leadership, assesses and develops talent, and ensures projects are staffed appropriately.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- 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 centres.
- 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 Required: moderate
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.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
- 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
Other Skills and Abilities
Ability to work with with MS Project, MS Excel, Time tracking tools