Job Description

Job Purpose

The Medical Device Engineer supports the design, development, testing, and maintenance of medical devices and related accessories within our organization. This role works under the direction of the Lead Engineer and collaborates closely with cross-functional teams, including Quality Assurance, Regulatory Affairs, Manufacturing, and Support Services. The Medical Device Engineer assists in engineering projects throughout the product lifecycle-from concept through production-while ensuring compliance with applicable standards and contributing to continuous improvement efforts.

This position provides hands-on engineering support, contributes to documentation and testing activities, helps resolve technical issues, and supports direct care support staff with device-related needs.

General Expectations

• Regular, reliable, and predictable attendance.
• Compliance with all applicable company policies, procedures, and patient protocols.
• Adherence to current government regulations and professional standards related to patient care.
• Maintain professionalism in all interactions and uphold company values.

Duties and Responsibilities

Engineering & Product Development

• Support engineering efforts to execute projects efficiently and in accordance with regulatory requirements.
• Assist in ensuring medical devices comply with relevant standards and contribute to regulatory documentation as needed.
• Participate in design and development activities, including prototyping, verification and validation testing, and iterative refinement.
• Help evaluate and document design risks, contributing to risk mitigation activities throughout the product lifecycle.
• Maintain accurate engineering documentation, drawings, test data, and revision histories.
• Maintain and run 3D printers and UV printers

Cross-Functional Collaboration

• Work closely with Quality Assurance to implement and maintain quality processes aligned with industry and regulatory standards.
• Collaborate with Regulatory Affairs to support submissions and address compliance requirements.
• Partner with Manufacturing to support smooth production transfer, build processes, and troubleshooting.
• Communicate effectively with internal teams to provide updates, highlight challenges, and propose solutions.

Technical & Support Functions

• Provide technical assistance to direct care support staff and assist in resolving device-related support tickets as assigned by the Lead Engineer.
• Support maintenance of technical manuals, knowledgebase content, and device documentation.
• Assist in the development and refinement of standard operating procedures related to device support and repair.

Additional Responsibilities

• Stay informed about relevant technologies, materials, and industry best practices.
• Perform all other duties as assigned by the Lead Engineer or management.

Experience & Qualifications

• BS in Mechanical Engineering or related engineering discipline required.
• Experience in medical device development, product engineering, or a related technical field preferred.
• Strong analytical, reasoning, and problem-solving abilities.
• Proficiency with engineering tools and software (e.g., CAD, Microsoft Office 365, SharePoint).
• Familiarity with quality systems (ISO 13485) and regulatory requirements (FDA, IEC standards) preferred but not required.
• Strong computer literacy, including familiarity with Windows 10, Apple iOS, and common hardware products.
• Excellent communication skills-verbal, written, and presentation.
• High attention to detail and commitment to accuracy.
• Customer-service mindset with the ability to support both internal and external stakeholders.
• Ability to manage multiple tasks and maintain organization in a fast-paced environment.
• Positive, collaborative attitude with willingness to learn and take direction.
• Must be able to pass required background and drug screenings.

Job Tags

Full time, Work at office,

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