Senior Mechanical Engineer
About The Position
The Senior Mechanical Engineer is an engineering leader with broad exposure to and experience with application of mechanical engineering theory and principles for electromechanical products. The Senior Mechanical Engineer is responsible for developing products, product improvements, managing and coordinating projects internally within Product Development and with external manufacturing partners. The Senior Mechanical Engineer is responsible for leading and mentoring lower-level engineers and interns in routine processes and selected tasks. Neuronetics is the industry leader in Transcranial Magnetic Stimulation (TMS) Therapy used in the treatment of drug resistant Major Depressive Order (MDD). TMS is cleared by the U.S. Food and Drug Administration (FDA) and uses a highly focused, pulsed magnetic field to stimulate function in brain regions known to affect mood. For more information, visit http://www.neurostar.com/
Requirements
- Bachelor’s degree in Mechanical Engineering
- 7+ years product development experience, with at least 3 years experience in a highly regulated environment.
- Must be proficient with SolidWorks 3D CAD.
- Must be proficient with Windows operating systems and Microsoft Office programs.
- Knowledge of machine design, injection molding processes, additive manufacturing, and 3D printing.
- Familiarity with Quality Management Systems in regulated environments.
- Knowledge of dFMEA and pFMEA and their application to design and manufacturing.
Nice To Haves
- Knowledge of regulatory requirements including but not limited to Risk Management, Electrical Safety and Usability
- Experience in the design and development of medical device systems or other FDA regulated products.
- Solid understanding of current safety and regulatory standards for medical devices.
- Skilled in estimating project resources, budgeting, work planning and tracking within a prescribed process.
Responsibilities
- Design, development and modeling of new products and product improvements.
- Design, prototype, build, and test design concepts from user inputs and/or from “white sheet of paper”
- Development of detailed product requirements, drawings, and documentation to support the product design.
- Design for manufacturability and assembly to support manufacturing partners.
- Cooperative development of assembly and test fixtures with manufacturing partners.
- Contribute to development of marketing, regulatory, and training documentation.
- Development of test plans, testing protocols, test reports, and test execution for verification and validation of products.
- Ability to present work for design reviews, workflow/design discussions and product demonstrations.
- Ability to develop and/or build prototypes using typical mechanical tools, 3D printers, and off the shelf components
- Other duties as required.
Benefits
- health insurance
- dental insurance
- vision insurance
- optional supplemental medical insurance
- health savings and flexible spending accounts
- company-paid life insurance and additional voluntary life insurance
- company-paid short term disability and long term disability insurance
- participation in a 401(k) savings and investment plan with company contribution
- paid time off for non-exempt salaried employees is calculated as .625 per pay period worked for vacation time and .29166 per pay period for personal time.
- Flex-PTO for full-time exempt employees
- paid sick leave (if applicable and required under state law)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
