Careers

FDA 510(k) Submissions: Lead and assist clients in preparing, reviewing, and submitting FDA 510(k) pre-market notifications for medical devices. Ensure compliance with relevant regulations and guidelines.

Design History File (DHF) Generation and Maintenance: Oversee and support the creation, review, and maintenance of DHFs for medical devices, documenting the product development process and ensuring alignment with applicable standards and requirements.

ISO 14971 Risk Analysis: Conduct comprehensive risk assessments for medical devices according to ISO 14971 standards. Work with clients to identify and mitigate potential risks associated with the design, manufacture, and use of their products.

IEC 62304 Requirements: Provide guidance and expertise on compliance with the IEC 62304 standard, ensuring clients’ software life cycle processes meet the necessary regulatory requirements.

Quality Management Systems (QMS): Assist clients in implementing and improving their QMS to comply with relevant quality standards, regulations, and industry best practices.

Audits and Inspections: Participate in audits and regulatory inspections, both internally and on behalf of clients. Hold ISO 13485 auditor and EU MDR certifications to support the resolution of any identified non-conformances and collaborate on corrective and preventive actions.

Training and Knowledge Sharing: Conduct training sessions and workshops for clients’ teams, imparting your expertise on quality assurance, regulatory compliance, and best practices in the medical device industry.

Continuous Improvement: Continuously evaluate and enhance internal processes and methodologies to ensure the delivery of high-quality consulting services to clients.

Industry Updates: Stay abreast of changing regulatory requirements, industry trends, and advancements in quality management practices, and apply this knowledge to support clients effectively.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field. ISO 13485:2016, EU MDR, and/or MDSAP training certifications are also preferred. Advanced degrees are advantageous.
• Proven experience (3-6 years) in quality engineering or related roles within the medical device industry including demonstrable evidence of:

Design History File (DHF) generation and/or remediation

Design Validation planning

Project Leadership

• Expertise in FDA 510(k) submissions, DHF generation and maintenance, ISO 14971 risk analysis, and familiarity with IEC 62304 requirements.
• Strong knowledge of quality management systems (e.g., ISO 13485) and regulatory frameworks (FDA, EU MDR, etc.).
• Experience in conducting audits, inspections, and interacting with regulatory agencies is a plus.
• Excellent problem-solving, analytical, and communication skills to effectively collaborate with clients and internal teams.
• Ability to work independently, manage multiple projects simultaneously, and meet tight deadlines.
• Strong attention to detail, and a passion for maintaining the highest quality standards.

Benefits:

• Collaborative team dedicated to working to support medical device innovation and compliance
• Remote working and flexible hours
• PTO
• Health and Dental Insurance
• 401k
• Employee training and certifications provided

Work as a quality consultant for medical device companies and various types of devices, diagnostics, and SaMD.

Provide Software Quality Engineering support for the design, risk analysis, and verification/validation of new medical device software products.

Strong working knowledge of IEC 62304, AAMI TIR45, Agile methodology, software design and testing.

Work closely with startup medical device companies and products to ensure all aspects of the software design file and risk management file are completed during the development process.

Assist product development teams during development of new devices and software to ensure proper documentation and records are created.

Responsible for implementation of product quality plans, verification/validation protocols and reports.

Maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements.

Qualifications:

• Bachelor’s degree or equivalent in Engineering or related field
• 1-3+ years’ of industry experience
• Strong knowledge of software development and tools used in the industry
• Analytical and quantitative approach to problem solving
• Strong communications skills

Benefits:

• Collaborative team dedicated to working to support medical device innovation and compliance
• Remote working and flexible hours
• PTO
• Health and Dental Insurance
• 401k
• Employee training and certifications provided