Design Engineer

POSITION TITLE: Design Engineer

LOCATION: Cleveland, Ohio (Hybrid)

REPORTS TO: Director of Research and Development

Basic Position Objective Statement:

The Design Engineer (DE) will work with the team to support the development, implementation of risk management processes, and validation activities within the Quality Management System (QMS). Key responsibilities include design of medical devices, maintaining design and risk management files, conducting hazard analyses, supporting design validation, and participating in audits. The DE will assist in risk analysis, design reviews, and quality control activities. The DE will collaborate cross-functionally to identify and mitigate potential risks, ensuring product safety and regulatory compliance while supporting company goals.

Principal Responsibilities and Accountabilities:

• Work with R&D and Engineering teams to establish and integrate risk management requirements at all phases of product design and development.
• Lead product design activities for neuro-implantable medical devices.
• Assist in the development and maintenance of Risk Management Files (RMF).
• Creation of drawings and specification for components and medical devices.
• Support design reviews, ensuring risk mitigation strategies are effectively implemented and documented.
• Assist in conducting post-market risk assessments, including the review of complaints, adverse events, and field data, to update risk management documentation as needed.
• Participate in internal and external audits, ensuring design management compliance.
• Develop and maintain documentation related to design control, process validation, and verification activities.
• Support the NCR, Complaint, and Corrective and Preventive Action (CAPA) processes, ensuring risk-based decision-making and verification of effectiveness.
• Support document control activities, ensuring risk management records are properly maintained and updated.
• Collaborate with manufacturing and quality teams to identify and mitigate risks in production processes, packaging, and labeling.
• Assist in the development and validation of test methods, inspection procedures, and verification protocols to ensure compliance with risk management requirements.
• Develop and perform validation testing protocols and reports.

Other assignments as made by management.

This is not an exhaustive list of duties or functions and may not necessarily comprise all the

“essential functions” for purposes of the ADA

Knowledge, Education and Training Qualifications and Certifications:

• BS/BA in engineering discipline is required.  Mechanical, electrical, or electro-mechanical engineering preferred.
• An advanced degree is a plus.
• A minimum of 1-3 years of experience in design engineering, validation engineering, or product development in the medical device industry.
• Demonstrated knowledge of ISO 14971 Risk Management for Medical Devices is preferred. 
• Demonstrated knowledge of ISO 13485 Medical Device Quality Management Systems is preferred.

Key Functional Competencies:

• Knowledgeable of FDA (21CFR 820), ISO 13485, and ISO 14971.
• Experience in risk management documentation, including the development and maintenance of Risk Management Files (RMF).
• Understanding of design verification and validation methods.
• Working knowledge of GD&T.
• CAD experience.
• Experience in/exposure to PCB design.
• Strong problem-solving and analytical skills for assessing potential product and process risks.
• Ability to work independently.
• Excellent verbal and written communication skills.
• Excellent interpersonal skills and a spirit of teamwork.

Key Performance Competencies:

• Demonstrated ability to work effectively within a culture defined by Neuronoff, Inc’s core values of achievement, teamwork, innovation and respect.
• Effective verbal and written communication skills are required.
• Excellent communications and influencing skills.  Establishes and maintains a high level of credibility.
• Collaborates effectively across the organization and across organizations; leverages resources from other parts of the organization to build commitment and achieve results.  Partners with other leaders and functions to achieve optimal results for Neuronoff, Inc.
• Objective; respects other points of view and opinions.  Leverages diverse perspectives and experiences to solve problems and develop new approaches.
• Organized; able to handle complexity and multiple priorities.  Manages time effectively and focuses on high priority opportunities.  Takes measured risks and takes appropriate action in the face of uncertainty.

Licenses/Certifications: N/A

Travel Requirements: 5% - 25% 

Physical Requirements:

The ability to work in a normal office environment to include:  sitting or standing for long periods of time, operating various standard office equipment, carrying paper documents/files, reaching and bending, speaking on the telephone, walking through a manufacturing plant, and wearing required personal protection gear (i.e. hearing, eye and foot protection).