Medical device Codes & Standards Engineer (New Product Design)

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Job Overview

The Medical Device Codes & Standards Engineer (New Product Design) at Select Source International will play a crucial role in ensuring compliance with regulatory standards and guidelines for new medical device designs. This position involves collaboration with cross-functional teams to identify applicable standards and regulatory requirements, conduct risk assessments, and facilitate testing and validation processes. The engineer will also be responsible for providing technical guidance and support throughout the product development lifecycle to ensure that designs meet safety, efficacy, and quality benchmarks.

Job Responsibilities

• Evaluate and interpret applicable codes and standards for new medical device product designs.
• Collaborate with R&D, quality assurance, and regulatory affairs teams to ensure compliance with relevant regulations.
• Conduct risk assessments and develop risk management plans in accordance with ISO 14971 guidelines.
• Facilitate the preparation and submission of technical files and design dossiers required for regulatory approvals.
• Assist in the development and implementation of test protocols to validate product performance against standards.
• Provide training and support to internal teams on industry standards and regulatory requirements.
• Stay abreast of emerging regulations and standards in the medical device industry.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.
• Minimum of 3 years of experience in medical device product design or a related engineering discipline.
• Strong understanding of FDA regulations, ISO standards, and other international standards applicable to medical devices.
• Proficiency in technical documentation and regulatory submission processes.
• Experience with risk management methodologies, including fault tree analysis and failure mode effects analysis (FMEA).
• Excellent communication skills, both verbal and written, with the ability to convey technical concepts to diverse audiences.
• Strong analytical and problem-solving skills, with attention to detail.

Technologies & Tools

The Medical Device Codes & Standards Engineer will utilize a variety of technologies and tools throughout their work. This includes design and simulation software such as SolidWorks and AutoCAD, as well as regulatory compliance management tools. Familiarity with quality management system (QMS) software, document control systems, and electronic lab notebooks (ELN) is also essential. The engineer may work with statistical analysis software for data evaluation and risk management tools to support their assessments.

Ideal Candidates

The ideal candidate for the position of Medical Device Codes & Standards Engineer will be a proactive and detail-oriented individual who possesses a strong technical foundation coupled with a passion for regulatory compliance in the healthcare sector. They should demonstrate exceptional organizational and multitasking abilities, enabling them to manage multiple projects simultaneously while maintaining high standards of quality. A collaborative mindset, along with the ability to work effectively in cross-functional teams, is crucial. Strong commitment to ongoing learning and adaptation to new regulatory requirements will further enhance their fit for this vital role.