Senior Mechanical Engineer

NeuroStar; Malvern (AR); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with company contribution

Paid time off

Job summary

Neuronetics is seeking a Senior Mechanical Engineer to lead design, development and testing of electromechanical medical devices. You will mentor junior engineers, coordinate projects with Product Development and external manufacturers, and contribute to regulatory documentation and design reviews.

Responsibilities include drafting detailed requirements, designing for manufacturability, and building prototypes using common mechanical tools and 3D printing.

Qualifications

• Bachelor's degree in Mechanical Engineering with 7+ years in product development.
• Experience in regulated environments and medical device knowledge preferred.
• Proficiency with SolidWorks for 3D CAD design.

Responsibilities

• Design, development and modeling of new products and improvements.
• Prototype, build and test concepts from inputs or from 'white sheet' ideas.
• Develop detailed product requirements, drawings and documentation.
• Design for manufacturability and assembly with manufacturing partners.
• Collaborate on fixtures with manufacturing partners and support testing.
• Develop test plans, protocols, reports and validation activities.
• Present work for reviews and demonstrations; mentor junior engineers.

Skills

Machine design

Injection molding

Additive manufacturing

3D printing

Mentoring / leadership

Regulated environment knowledge

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Windows

Microsoft Office

Job description

Position Overview:

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/

Essential Duties/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.

Knowledge, Skill, and Abilities:

• Knowledge of machine design, injection molding processes, additive manufacturing, and 3D printing.
• Familiarity with Quality Management Systems in regulated environments.
• Knowledge of machine design, injection molding processes, additive manufacturing, and 3D printing.
• Knowledge of dFMEA and pFMEA and their application to design and manufacturing.

Education and Experience:

• 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.

Preferred Skills:

• 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.

Physical Requirements

• Occasional travel to suppliers, contract manufacturers, contract design firms, etc. up to 10% maximum.
• Ability to lift at least 50lbs safely.
• Applicants must be authorized to work for any employer in the US. We are unable to sponsor or assume responsibility for employment visa/work authorization at this time.

Neuronetics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Neuronetics/Greenbrook makes hiring decisions based solely on qualifications, merit, and/or business needs at the time.

We are committed to providing equal employment opportunities to individuals with disabilities and protected veterans.

Benefits Statement:

Selected candidate will be eligible to participate in the Company's employee benefit plans, which currently include: 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; and 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. Full-time exempt employees will be eligible for Flex-PTO, which allows time off without accrual. If applicable and required under state law, the successful candidate will also be eligible for paid sick leave. These benefits are subject to plan terms, company policies and are subject to change.

About Us

Neuronetics, together with Greenbrook Mental Wellness Centers, delivers innovative mental health treatments through FDA-cleared NeuroStar TMS and Spravato therapies. Our mission is to expand access to life-changing care, combining cutting-edge technology, compassionate patient support, and clinical excellence to improve lives every day. Join us in making a meaningful impact in the rapidly growing mental health field.