Senior Mechanical Engineer

NeuroStar; Malvern (Chester County); On-site; USD 110,000 - 160,000; Full time

Job summary

Neuronetics, a leader in TMS therapy, seeks a Senior Mechanical Engineer to drive design and product development for electromechanical medical devices in a regulated environment. You will mentor junior engineers, coordinate with external manufacturers, and contribute to verification and validation activities.

The role emphasizes design for manufacturability, robust documentation, and collaboration across R&D, regulatory, and quality teams to bring innovative medical devices to market.

Qualifications

• Bachelor's degree in Mechanical Engineering.
• 7+ years of product development experience, incl. regulated environments.
• Proficiency in SolidWorks 3D CAD.
• Experience with design for manufacturability and medical device standards.

Responsibilities

• Design, develop and model new products and improvements.
• Prototype, build, and test concepts from scratch.
• Create detailed product requirements, drawings and documentation.
• Design for manufacturability with manufacturing partners.
• Develop fixtures with manufacturing partners.
• Contribute to marketing, regulatory and training documentation.
• Develop test plans, protocols, reports and execution.
• Present work for reviews and demonstrations.
• Build prototypes using mechanical tools and 3D printers.

Skills

Machine design

Injection molding

Additive manufacturing

3D printing

Quality Management Systems

dFMEA / pFMEA

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks 3D CAD

Windows OS

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

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.

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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.