Senior Mechanical Engineer

Posted Yesterday
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Malvern, PA, USA
In-Office
Senior level
Hardware • Healthtech
The Role
Leads mechanical engineering design and development for regulated electromechanical medical devices. Responsibilities include product modeling, prototyping, testing, requirements and documentation, design for manufacturability, fixture development, verification and validation, regulatory support, design reviews, and mentoring engineers. The role requires SolidWorks proficiency, experience with manufacturing processes and quality systems, and collaboration with suppliers and manufacturing partners. Occasional travel of up to 10% is required, along with the ability to lift 50 pounds.
Summary Generated by Built In

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.

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.

GBSP25

Skills Required

  • Bachelor's degree in Mechanical Engineering
  • 7+ years of product development experience
  • At least 3 years of experience in a highly regulated environment
  • Proficiency with SolidWorks 3D CAD
  • Proficiency with Windows operating systems and Microsoft Office programs
  • Authorized to work for any employer in the United States
  • Knowledge of regulatory requirements, including risk management, electrical safety, and usability
  • Experience designing and developing medical device systems or other FDA-regulated products
  • Understanding of current medical device safety and regulatory standards
  • Experience estimating project resources, budgeting, work planning, and tracking
  • Ability to travel to suppliers, contract manufacturers, and contract design firms up to 10%
  • Ability to safely lift at least 50 pounds
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The Company
HQ: Malvern, PA
658 Employees
Year Founded: 2003

What We Do

Neuronetics, Inc. is a commercial-stage medical technology company focused on designing, developing, and marketing products that improve quality of life for people with neurohealth disorders. Its NeuroStar Advanced Therapy for Mental Health is a non-drug, noninvasive transcranial magnetic stimulation treatment. Following its Greenbrook acquisition, the company also operates mental-health treatment centers offering NeuroStar TMS and Spravato for depression and related disorders.

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