Senior Design Quality Engineer

Pentangle Tech Services | P5 Group; United States; On-site; USD 90,000 - 140,000; Full time

Job summary

Pentangle Tech Services | P5 Group is seeking a Design Quality Engineer to lead ISO 14971 risk management across the product lifecycle for medical devices. You will partner with R&D, Regulatory Affairs, Manufacturing, and Quality Systems to ensure compliant design and robust risk controls.

The ideal candidate has hands-on experience with DFMEA/PFMEA, design controls, and post-market activities, and can guide teams in risk-based decision making. Strong communication skills are essential.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related field).
• 3–5 years of experience in medical device design quality, design assurance, or risk management.
• Strong working knowledge of ISO 14971, ISO 13485, and QSR/21 CFR Part 820.
• Hands-on experience creating and maintaining risk management files for Class I, II, or III medical devices.
• Proficiency with risk analysis tools (DFMEA, PFMEA, FTA, hazard analysis).
• Excellent communication skills and the ability to influence engineering teams.

Responsibilities

• Lead the development, execution, and maintenance of risk management files in accordance with ISO 14971, including hazard analysis, FMEA, fault tree analysis, and benefit–risk assessments.
• Support design control activities per QSR/21 CFR 820.30 and ISO 13485, ensuring risk management is fully integrated into design planning, verification, validation, and design transfer.
• Collaborate with cross‑functional teams to identify potential hazards, evaluate risks, and implement effective risk controls.
• Review and approve design documentation, engineering changes, and technical files for compliance with internal procedures and regulatory requirements.
• Participate in design reviews, providing expert guidance on risk mitigation strategies and usability considerations.
• Ensure traceability between design inputs, risk controls, verification/validation activities, and product requirements.
• Support regulatory submissions by preparing and reviewing risk management documentation.
• Contribute to post‑market surveillance activities, including complaint analysis, CAPA investigations, and risk file updates.
• Drive continuous improvement of risk management processes, tools, and templates.
• Provide training and mentorship to engineering teams on risk management best practices.

Skills

Risk management

Design controls

Analytical skills

Regulatory communication

Problem solving

Education

Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related)

Tools

DFMEA

PFMEA

FTA

Hazard analysis

Job description

The Design Quality Engineer will play a central role in ensuring the safety, reliability, and regulatory compliance of new and existing medical device products. This position focuses heavily on ISO 14971–compliant risk management throughout the product lifecycle, partnering closely with R&D, Regulatory Affairs, Manufacturing, and Quality Systems teams. The ideal candidate brings strong analytical skills, deep understanding of design controls, and hands‑on experience guiding engineering teams through risk‑based decision‑making.

Responsibilities

• Lead the development, execution, and maintenance of risk management files in accordance with ISO 14971, including hazard analysis, FMEA, fault tree analysis, and benefit–risk assessments.
• Support design control activities per QSR/21 CFR 820.30 and ISO 13485, ensuring risk management is fully integrated into design planning, verification, validation, and design transfer.
• Collaborate with cross‑functional teams to identify potential hazards, evaluate risks, and implement effective risk controls.
• Review and approve design documentation, engineering changes, and technical files for compliance with internal procedures and regulatory requirements.
• Participate in design reviews, providing expert guidance on risk mitigation strategies and usability considerations.
• Ensure traceability between design inputs, risk controls, verification/validation activities, and product requirements.
• Support regulatory submissions by preparing and reviewing risk management documentation.
• Contribute to post‑market surveillance activities, including complaint analysis, CAPA investigations, and risk file updates.
• Drive continuous improvement of risk management processes, tools, and templates.
• Provide training and mentorship to engineering teams on risk management best practices.

Required Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related field).
• 3–5 years of experience in medical device design quality, design assurance, or risk management.
• Strong working knowledge of ISO 14971, ISO 13485, and QSR/21 CFR Part 820.
• Hands‑on experience creating and maintaining risk management files for Class I, II, or III medical devices.
• Proficiency with risk analysis tools (e.g., DFMEA, PFMEA, FTA, hazard analysis).
• Experience supporting design controls and product development processes.
• Excellent communication skills and the ability to influence engineering teams.
• Strong analytical and problem‑solving abilities.

Preferred Qualifications

• Experience with Notified Body audits or FDA inspections.
• Risk management certification (e.g., ISO 14971 lead auditor/lead implementer) is a plus.