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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