Lumicity
Responsibilities
Serve as the primary quality representative within cross‑functional product development teams, ensuring adherence to regulatory requirements and quality best practices.
Lead quality deliverables such as Project Design & Development Plans, Field Assessment Plans, Design Changes, and Design & Usability Validation Plans. Ensure compliance with ISO 14971 and demonstrate a strong commitment to patient safety.
Lead Risk Management activities and documentation throughout the design process.
Function as a project leader or specialized technical team lead with cross‑functional impact, including division‑level representation on cross‑divisional quality system initiatives.
Apply systematic problem‑solving tools such as 5 Whys, Is‑Is Not, DMAIC, and Six Sigma to drive root cause identification and corrective actions.
Mentor and coach engineers in quality engineering principles and problem‑solving methodologies to promote a culture of learning and continuous improvement.
Communicate quality priorities and recommendations to stakeholders across departments, using influence and negotiation to integrate quality into strategic decisions.
Identify and implement improvements to quality systems and practices, championing best‑in‑class standards.
Act as a subject matter expert during internal and external regulatory audits; support audit responses and submissions through high‑quality technical writing.
Required Qualifications
Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.
Minimum of 5 years’ experience in medical device engineering.
Detailed understanding of U.S. and international regulatory requirements including 21 CFR Part 820, MDD/EU MDR, ISO 13485, and ISO 14971.
Ability to travel approximately 10–20%.
Preferred Qualifications
Minimum of 3 years experience in medical device engineering.
Proficiency with Minitab or equivalent statistical analysis software.
Strong expertise in design controls, quality engineering, risk management, and technical problem‑solving.
Excellent communication and interpersonal skills with proven ability to influence teams and leadership.
Demonstrated leadership and mentoring capabilities in a quality‑driven environment.
Strategic mindset with the ability to manage hands‑on project needs and long‑term initiatives.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance, Engineering, and Design
Industries Medical Equipment Manufacturing
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Serve as the primary quality representative within cross‑functional product development teams, ensuring adherence to regulatory requirements and quality best practices.
Lead quality deliverables such as Project Design & Development Plans, Field Assessment Plans, Design Changes, and Design & Usability Validation Plans. Ensure compliance with ISO 14971 and demonstrate a strong commitment to patient safety.
Lead Risk Management activities and documentation throughout the design process.
Function as a project leader or specialized technical team lead with cross‑functional impact, including division‑level representation on cross‑divisional quality system initiatives.
Apply systematic problem‑solving tools such as 5 Whys, Is‑Is Not, DMAIC, and Six Sigma to drive root cause identification and corrective actions.
Mentor and coach engineers in quality engineering principles and problem‑solving methodologies to promote a culture of learning and continuous improvement.
Communicate quality priorities and recommendations to stakeholders across departments, using influence and negotiation to integrate quality into strategic decisions.
Identify and implement improvements to quality systems and practices, championing best‑in‑class standards.
Act as a subject matter expert during internal and external regulatory audits; support audit responses and submissions through high‑quality technical writing.
Required Qualifications
Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.
Minimum of 5 years’ experience in medical device engineering.
Detailed understanding of U.S. and international regulatory requirements including 21 CFR Part 820, MDD/EU MDR, ISO 13485, and ISO 14971.
Ability to travel approximately 10–20%.
Preferred Qualifications
Minimum of 3 years experience in medical device engineering.
Proficiency with Minitab or equivalent statistical analysis software.
Strong expertise in design controls, quality engineering, risk management, and technical problem‑solving.
Excellent communication and interpersonal skills with proven ability to influence teams and leadership.
Demonstrated leadership and mentoring capabilities in a quality‑driven environment.
Strategic mindset with the ability to manage hands‑on project needs and long‑term initiatives.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance, Engineering, and Design
Industries Medical Equipment Manufacturing
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