Senior Mechanical Engineer

Cytrellis Biosystems, Inc.; Woburn (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading medical device company in Woburn, MA is seeking a Senior Mechanical Engineer to design and develop mechanical systems for medical devices. The ideal candidate will drive innovation, ensure compliance with regulatory standards, and collaborate with cross-functional teams. Experience in mechanical design and strong project management skills are essential. This role offers an exciting opportunity to contribute to medical technology innovation.

Qualifications

• Experience in mechanical system design and development for medical devices.
• Strong understanding of regulatory requirements for medical devices.
• Ability to manage project timelines and resources effectively.

Responsibilities

• Design, develop, and implement mechanical systems for medical devices.
• Drive continuous improvement in design processes.
• Provide mentorship to engineering peers.
• Participate in risk management and ensure product safety.

Skills

Collaboration with cross-functional teams

Innovation in system design

Technical guidance and mentorship

Knowledge of regulatory standards (FDA, CE, ISO)

Job description

Description

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.

This role is located at the Company’s headquarters in Woburn, MA.

Requirements

• 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.
• Manage project timelines, budgets, and resources to meet product development goals.
• Stay current with industry trends, emerging technologies, and regulatory changes related to medical devices and mechanical engineering.