Bachelor's Degree in Engineering, Science, or a related technical discipline
5+ years of experience in the Medical Device industry
Experience performing Process Verification and Validation activities
Strong knowledge of Design Controls and Quality Systems
Excellent problem-solving and analytical skills
Strong communication and cross-functional collaboration skills
Advanced degree (MS or higher) preferred, particularly in Mechanical or Biomedical Engineering
Responsibilities
Support design changes and process improvements throughout the product lifecycle
Lead and execute Design Verification & Validation (V&V) activities
Conduct Design and Process FMEA to identify and mitigate risks
Ensure compliance with Design Controls and applicable medical device regulations
Collaborate with various teams to support product development
Drive risk management activities and support change control processes
Participate in CAPA investigations and implementation
Benefits
Professional development through continuous improvement initiatives
Opportunity to collaborate with cross-functional teams
Engagement in high-impact projects within the medical device lifecycle
A role that emphasizes compliance with leading industry standards
Possibility for career advancement with an advanced degree preference
Full Job Description
Job Summary:
The Senior Design Quality Engineer will support product lifecycle management activities for medical devices by providing quality engineering leadership for design and process changes, risk management, verification and validation activities, and compliance with medical device regulations.
The role requires close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, Marketing, and Operations.
Roles & Responsibilities:
Support design changes and process improvements throughout the product lifecycle.
Lead and execute Design Verification & Validation (V&V) activities.
Conduct Design FMEA and Process FMEA to identify and mitigate product and process risks.
Ensure compliance with Design Controls and applicable medical device regulations.
Collaborate with R&D, Manufacturing, Regulatory Affairs, and Marketing teams to support product development and sustaining engineering initiatives.
Drive risk management activities and support change control processes.
Participate in corrective and preventive action (CAPA) investigations and implementation.
Support nonconforming material investigations and quality system improvements.
Review and approve engineering documentation, protocols, reports, and design history files.
Provide technical leadership for quality engineering projects and continuous improvement initiatives.
Ensure compliance with applicable quality standards and regulatory requirements.
Education & Experience:
Bachelor's Degree in Engineering, Science, or a related technical discipline.
5+ years of experience in the Medical Device industry.
Experience performing Process Verification and Validation activities.
Experience conducting Design FMEA and/or Process FMEA.
Strong knowledge of Design Controls and Quality Systems.
Excellent problem-solving, analytical, and decision-making skills.
Strong communication and cross-functional collaboration skills.
bility to manage multiple priorities and lead technical projects.
dvanced degree (MS or higher) preferred.
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related discipline preferred.
Experience in New Product Development (NPD).
Strong understanding of blueprint reading, inspection methods, and GD&T.
Experience with Design Excellence, Lean Manufacturing, and Six Sigma methodologies.
Medical device lifecycle management experience.
Knowledge of FDA, ISO 13485, and risk management standards.
