R&D Engineer/ Quality Engineer/OR mechanical engineer

R&D Engineer/Quality Engineer/OR Mechanical Engineer

We are seeking a highly experienced Level III Quality Systems Engineer to join our Quality and Regulatory team. This role is critical in ensuring the integrity and compliance of marketing claims associated with our medical devices. The ideal candidate will have a strong background in quality systems within the medical device industry and a proven ability to trace marketing claims to supporting engineering analyses and documentation. This individual will also be responsible for developing and maintaining SOPs related to the establishment and validation of marketing claims, with a focus on different user populations.

In addition, this role will involve collecting and reviewing existing documentation to identify and substantiate claims, and later, training key stakeholders on the newly developed claims process to ensure consistent understanding and implementation across the organization.

Key Responsibilities:

• Marketing Claims Validation:
• Collect and review existing internal documentation to identify potential marketing claims.
• Organize and document findings to support traceability and validation efforts with internal project team.
• Investigate and validate marketing claims by tracing them to engineering analyses, risk assessments, and supporting technical documentation.
• Evaluate claims for accuracy, scientific validity, and compliance with regulatory standards (e.g., FDA, ISO 13485).
• Assess claims made for different user populations to ensure appropriate substantiation.
• Traceability and Documentation:
• Utilize Pepper Flow software to manage and maintain traceability of claims to source documentation.
• Ensure all documentation is audit-ready and compliant with internal and external quality standards.
• SOP Development and Maintenance:
• Develop, implement, and maintain Standard Operating Procedures (SOPs) for the creation, review, and approval of marketing claims.
• Collaborate with cross-functional teams (Marketing, R&D, Regulatory, Clinical) to align SOPs with business and compliance needs.
• Cross-Functional Collaboration:
• Partner with Regulatory Affairs to ensure claims meet global regulatory requirements.
• Work closely with Engineering and Clinical teams to gather and interpret data supporting claims.
• Provide training and guidance to internal stakeholders on claim substantiation processes.
• Stakeholder Training:
• Design and deliver training sessions for key stakeholders on the new claims process.
• Ensure consistent understanding and adoption of the process across relevant departments.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).
• 810 years of experience in Quality Systems or Regulatory Affairs within the medical device industry.
• Strong understanding of FDA regulations, ISO 13485, and other relevant standards.
• Experience with Pepper Flow or similar document control/traceability systems.
• Demonstrated ability to critically evaluate scientific and engineering data.
• Excellent written and verbal communication skills.
• Strong organizational and project management skills.

Preferred Skills:

• Familiarity with global regulatory environments (e.g., EU MDR, Health Canada).
• Prior experience developing SOPs and quality documentation.
• Knowledge of human factors and usability engineering as it relates to different user populations.