Job Description
Our client in Woburn, MA is looking to bring on a Mechanical Engineer. Our client is looking for candidates who come from the medical device industry. The role is a direct hire with full benefits.
Responsibilities
- As a Senior Mechanical Engineer, you will be responsible for the design, development, and implementation of mechanical systems and components for medical devices in compliance with regulatory standards.
- Work with engineers across disciplines in the design and development of medical devices from concept to production.
- Drive innovation and continuous improvement in system design processes and methodologies.
- Collaborate closely with cross-functional teams including R&D, product management, quality assurance, and regulatory affairs to ensure successful product development.
- Establish and maintain design control processes to ensure compliance with regulatory requirements such as FDA, CE, and ISO.
- Provide technical guidance and mentorship to the peers, fostering a culture of excellence and accountability.
- Participate in risk management activities and provide input on design mitigations to ensure product safety and efficacy.
Qualifications
- Bachelor’s degree in Mechanical Engineering; Master’s degree preferred.
- 5+ years of experience in mechanical engineering, with 3+ years of experience in the medical device industry.
- Proven track record of successfully leading and managing cross-functional engineering teams in the development of medical devices.
- Strong understanding of mechanical design principles, materials selection, and manufacturing processes relevant to medical devices.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal teams and external partners.
- Experience with solid modeling (SolidWorks), engineering drawings, GD&T, and design for manufacturability and assembly (DFMA).
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