Engineer - Design Quality
Apply NowCompany: Diverse Lynx LLC
Location: Irvine, CA 92620
Description:
Key Responsibilities:
pply Design Quality principles in product development and manufacturing processes.
Utilize GMP (Good Manufacturing Practices) to ensure compliance with FDA and ISO 13485 regulations.
Manage CAPA/NC (Corrective and Preventive Actions / Non-Conformance) and lead Root Cause Analysis processes.
Perform Design Failure Mode and Effects Analysis (DFMEA) and Process Failure Mode and Effects Analysis (PFMEA).
Contribute to the Post-Market Surveillance (PMS) process.
Develop and maintain Quality Management Systems and support audits.
Utilize PLM tools (e.g., Windchill) for product lifecycle management.
Ensure compliance with Medical Device Regulatory Standards, including MDD and MDR.
Collaborate with cross-functional teams to solve problems and improve processes.
Prepare reports, track progress, and communicate status effectively to stakeholders.
Qualifications:
Bachelor's Degree in Engineering, Science, or a related technical field.
5+ years of experience in Design Quality and medical device regulatory compliance.
Strong knowledge of FDA, ISO 13485, and other medical device regulations.
Experience with GMP, CAPA/NC, Root Cause Analysis, and audit processes.
Familiarity with FMEAs, risk management, and design control.
Proficiency in CAD and understanding of GD&T (Geometric Dimensioning and Tolerancing).
Excellent verbal and written communication skills.
Proficiency with Project Management methodology, problem-solving, and presentation skills.
Experience with Post-Market Surveillance (PMS) and PLM tools (e.g., Windchill).
bility to work efficiently, manage timelines, and communicate progress.
Preferred Skills:
Strong interpersonal, organizational, and planning skills.
Proficient with Microsoft Office (Word, PowerPoint, Excel, Outlook).
Experience in Medical Device & Regulations is highly preferred.
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
pply Design Quality principles in product development and manufacturing processes.
Utilize GMP (Good Manufacturing Practices) to ensure compliance with FDA and ISO 13485 regulations.
Manage CAPA/NC (Corrective and Preventive Actions / Non-Conformance) and lead Root Cause Analysis processes.
Perform Design Failure Mode and Effects Analysis (DFMEA) and Process Failure Mode and Effects Analysis (PFMEA).
Contribute to the Post-Market Surveillance (PMS) process.
Develop and maintain Quality Management Systems and support audits.
Utilize PLM tools (e.g., Windchill) for product lifecycle management.
Ensure compliance with Medical Device Regulatory Standards, including MDD and MDR.
Collaborate with cross-functional teams to solve problems and improve processes.
Prepare reports, track progress, and communicate status effectively to stakeholders.
Qualifications:
Bachelor's Degree in Engineering, Science, or a related technical field.
5+ years of experience in Design Quality and medical device regulatory compliance.
Strong knowledge of FDA, ISO 13485, and other medical device regulations.
Experience with GMP, CAPA/NC, Root Cause Analysis, and audit processes.
Familiarity with FMEAs, risk management, and design control.
Proficiency in CAD and understanding of GD&T (Geometric Dimensioning and Tolerancing).
Excellent verbal and written communication skills.
Proficiency with Project Management methodology, problem-solving, and presentation skills.
Experience with Post-Market Surveillance (PMS) and PLM tools (e.g., Windchill).
bility to work efficiently, manage timelines, and communicate progress.
Preferred Skills:
Strong interpersonal, organizational, and planning skills.
Proficient with Microsoft Office (Word, PowerPoint, Excel, Outlook).
Experience in Medical Device & Regulations is highly preferred.
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.