Sr. Design Quality Engineering

Simarn Solutions; Irvine (CA); Hybrid; USD 57,859 - 79,900; Full time

Job summary

Simarn Solutions in Irvine, CA seeks a Sr. Design Quality Engineer to ensure product quality compliance, support risk management, and lead verification and validation activities across design control. The role requires hands-on problem-solving and cross-functional collaboration.

You will work with engineering, manufacturing and quality teams to drive DFMEA/PFMEA, V&V plans, and data analysis using Minitab, delivering clear technical documentation for stakeholders.

Qualifications

• Experience with quality engineering in manufacturing or medical device environments.
• Strong knowledge of design control, risk management, and process validation.
• Hands-on DFMEA, PFMEA, V&V activities, and statistical tools (Minitab).

Responsibilities

• Ensure quality engineering activities meet regulatory and internal standards.
• Support development and execution of V&V plans, protocols, and reports.
• Perform Test Method Validation and process validation (PFMEA, IQ, OQ, PQ).
• Use statistical tools such as Minitab for data analysis.
• Oversee product testing to ensure compliance with applicable requirements.
• Apply Design Control principles to support sustaining engineering and product updates.
• Resolve quality issues and support design changes with cross‑functional teams.
• Apply risk management techniques to identify and mitigate product risks.
• Use structured problem‑solving methodologies to address product and process challenges.
• Prepare technical documentation, reports, and presentations for stakeholders.

Skills

Quality engineering

Design control

Risk management

Problem-solving

Cross-functional collaboration

Communication

Tools

Minitab

DFMEA

PFMEA

V&V

Job description

About the job Sr. Design Quality Engineering

Sr. Design Quality Engineering
Location: Irvine, California
Job Type: C2C | Hybrid
Pay Rate: $50/hr
Industry: Manufacturing / Medical Devices
End Date: 01-Jan-2026

Job Description

We are seeking a Sr. Design Quality Engineering professional experienced in ensuring product quality compliance, supporting risk management activities, and leading verification and validation processes. The role requires strong collaboration with cross‑functional teams, hands‑on involvement in design control, and the ability to resolve quality issues through structured problem‑solving and risk‑based approaches.

Responsibilities

• Ensure quality engineering activities meet regulatory and internal standards.
• Support development and execution of V&V plans, protocols, and reports.
• Perform Test Method Validation and process validation (PFMEA, IQ, OQ, PQ).
• Use statistical tools such as Minitab for data analysis.
• Oversee product testing to ensure compliance with applicable requirements.
• Apply Design Control principles to support sustaining engineering and product updates.
• Resolve quality issues and support design changes with cross‑functional teams.
• Apply risk management techniques to identify and mitigate product risks.
• Use structured problem‑solving methodologies to address product and process challenges.
• Prepare technical documentation, reports, and presentations for stakeholders.

Required Qualifications

• Experience with quality engineering in manufacturing or medical device environments.
• Strong knowledge of design control, risk management, and process validation.
• Hands‑on experience with DFMEA, PFMEA, V&V activities, and statistical tools (Minitab).
• Ability to support sustaining engineering and design updates.
• Strong analytical, communication, and problem‑solving skills.
• Experience collaborating with engineering, manufacturing, and quality teams.