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Cytrellis Biosystems, Inc. · 2 months ago

Senior Mechanical Engineer

Woburn,MA,US

Full-time

Onsite

Senior Level

Cytrellis Biosystems, Inc. is seeking a Senior Mechanical Engineer responsible for the design, development, and implementation of mechanical systems and components for medical devices. This role involves collaboration with cross-functional teams to ensure compliance with regulatory standards and successful product development.

BiotechnologyHealth CareMedical

Responsibilities

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

Qualification

Mechanical EngineeringMedical Device DesignRegulatory ComplianceProject ManagementTechnical Guidance

Required