Risk Control Design Quality Engineer

Actalent•Fremont, CA

33d•$135,200 - $156,000•Onsite

About The Position

Join a dynamic team dedicated to ensuring the highest standards of risk management in design quality. As a Risk Control Design Quality Engineer, you will play a pivotal role in mentoring a team of quality engineers and guiding best practices to enhance product safety and compliance.

Requirements

Expert-level knowledge of ISO standards, 21 CFR Part 820, and related regulatory frameworks.
Demonstrated leadership in risk management activities across multiple product development projects.
Strong analytical and problem-solving skills with experience in statistical analysis and risk quantification.
Excellent communication and interpersonal skills, with a proven ability to mentor and influence cross-functional teams.
Experience in EU MDR.
Bachelor's or Master's degree in Engineering, Biomedical Sciences, or related field.
Minimum 10 years of experience in Design Quality Assurance and risk management within the medical device industry.

Nice To Haves

Certified Quality Engineer (CQE) or Risk Management certification preferred.
Experience with Class II or Class III medical devices.
Familiarity with electronic quality management systems (eQMS) and document control platforms.
Experience supporting M&A or integration projects from a risk management perspective.

Responsibilities

Serve as the subject matter expert in risk management for design quality, guiding junior engineers and cross-functional teams.
Lead the development, execution, and maintenance of risk management files in accordance with ISO standards and 21 CFR Part 820.
Drive hazard analysis, FMEA (Design and Process), fault tree analysis, and other risk assessment methodologies throughout the product lifecycle.
Collaborate with R&D, Regulatory, Clinical, and Manufacturing teams to ensure risk controls are properly implemented and verified.
Review and approve design documentation, including Design History Files (DHF), Design Inputs/Outputs, and Verification/Validation protocols.
Provide strategic input during design reviews, ensuring risk mitigation strategies are comprehensive and compliant.
Lead training and mentoring efforts for junior engineers on risk management principles, tools, and regulatory expectations.
Support internal and external audits, including FDA and Notified Body inspections, as the risk management representative.
Continuously improve risk management processes and tools to enhance product safety and compliance.