Mechanical Engineer
Overview
An innovative medical device company is seeking a Mechanical Engineer to support the development and manufacturing transfer of advanced Class II and III medical technologies. The organization is committed to improving patient outcomes through cutting-edge product development and a collaborative, mission-driven culture.
This is an exciting opportunity to join a growing team where you'll work on meaningful projects, contribute to new product development, and help bring life-changing medical devices to market.
Responsibilities
- Contribute to the design and development of Class II and III medical devices, including mechanical packaging of components and system-level integration.
- Design and develop fixtures, tooling, and mechanical components using SolidWorks, with a strong emphasis on design for manufacturability and assembly (DFM/DFA).
- Create and maintain detailed engineering documentation, including 3D models, 2D drawings, bills of materials (BOMs), and engineering change orders (ECOs).
- Collaborate with cross-functional teams-including R&D, Quality, Regulatory, and Manufacturing-to support new product introduction (NPI) and ensure smooth transfer to production.
- Troubleshoot and resolve issues related to mechanical design, material flow, and final test processes in a production environment.
- Participate in formal design reviews, risk assessments, and verification/validation activities in accordance with the company's gated product development process.
- Generate and maintain documentation in compliance with medical device regulations and internal SOPs, including work instructions, test protocols, travelers, and device history files (DHFs).
Qualifications
- Bachelor's degree in Mechanical or Manufacturing Engineering.
- Minimum of 3 years of experience in the medical device industry, specifically with Class II or III devices.
- Proven experience in new product development (NPD), from concept through to production transfer.
- Proficiency with SolidWorks or a similar 3D CAD system; familiarity with PLM systems is a plus.
- Strong hands-on mechanical aptitude and a passion for building and understanding how things work.
- Proficiency in Microsoft Word and Excel; ability to learn systems such as Arena PLM.
FAQs
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