Design Quality Engineer - FULLY REMOTE

Actalent; Fremont (CA); Remote; USD 83,000 - 92,000; Part time

Job summary

Actalent is seeking a Design Quality Engineer to lead ISO-based risk management for medical devices across the lifecycle. The role collaborates with R&D, Regulatory Affairs, Manufacturing, and Quality Systems to ensure design controls align with QSR/21 CFR 820.30 and to maintain robust risk documentation.

Based in Fremont, CA, this contract position offers exposure to hazard analysis, FMEA, and post-market surveillance, with opportunities to mentor teams and drive continuous improvement in risk

Qualifications

• Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, or related field).
• 35 years of experience in medical device design quality, design assurance, or risk management.
• Strong working knowledge of ISO-based risk management standards and QSR/21 CFR Part 820 requirements for medical devices.
• Hands-on experience creating and maintaining risk management files for Class I, II, or III medical devices.
• Proficiency with risk analysis tools, including DFMEA, PFMEA, fault tree analysis (FTA), and hazard analysis.
• Experience supporting design controls and product development processes within a regulated medical device environment.
• Excellent written and verbal communication skills, with the ability to influence and guide engineering teams and cross-functional stakeholders.
• Strong analytical and problem-solving abilities, with a structured and detail-oriented approach to risk assessment and mitigation.

Responsibilities

• Lead the development, execution, and maintenance of comprehensive risk management files in accordance with ISO standards, including hazard analysis, FMEA, fault tree analysis, and benefit-risk assessments.
• Support design control activities in alignment with QSR/21 CFR 820.30, ensuring risk management is fully integrated into design planning, design inputs and outputs, verification, validation, and design transfer.
• Collaborate with cross-functional teams to identify potential hazards, evaluate associated risks, and implement effective risk controls for medical device designs.
• Review and approve design documentation, engineering changes, and technical files to ensure compliance with internal procedures and applicable regulatory requirements.
• Participate in design reviews, providing expert guidance on risk mitigation strategies, usability considerations, and overall design robustness.
• Ensure clear traceability between design inputs, risk controls, verification and validation activities, and final product requirements.
• Support regulatory submissions by preparing and reviewing risk management documentation that demonstrates compliance and sound risk-based decision-making.
• Contribute to post-market surveillance activities, including complaint analysis, CAPA investigations, and updates to risk management files based on field performance and feedback.
• Drive continuous improvement of risk management processes, tools, and templates to enhance efficiency, consistency, and regulatory alignment.
• Provide training and mentorship to engineering and cross-functional teams on risk management best practices, tools, and methodologies.

Skills

ISO risk management

FMEA

PFMEA

FTA

Hazard analysis

Design controls

Regulatory awareness

Cross-functional

Documentation

Communication

Education

Bachelors in Engineering

Tools

DFMEA

PFMEA

FTA

Hazard analysis

Job description

Job Title: Design Quality Engineer

Job Description

The Design Quality Engineer plays a central role in ensuring the safety, reliability, and regulatory compliance of new and existing medical device products. This position focuses on ISO-compliant risk management throughout the entire product lifecycle and requires close collaboration with R&D, Regulatory Affairs, Manufacturing, and Quality Systems teams. The role is ideal for an engineer with strong analytical skills, a deep understanding of design controls, and hands‑on experience guiding engineering teams through risk‑based decision‑making for medical devices.

Responsibilities

• Lead the development, execution, and maintenance of comprehensive risk management files in accordance with ISO standards, including hazard analysis, FMEA, fault tree analysis, and benefitrisk assessments.

• Support design control activities in alignment with QSR/21 CFR 820.30, ensuring risk management is fully integrated into design planning, design inputs and outputs, verification, validation, and design transfer.

• Collaborate with cross‑functional teams to identify potential hazards, evaluate associated risks, and implement effective risk controls for medical device designs.

• Review and approve design documentation, engineering changes, and technical files to ensure compliance with internal procedures and applicable regulatory requirements.

• Participate in design reviews, providing expert guidance on risk mitigation strategies, usability considerations, and overall design robustness.

• Ensure clear traceability between design inputs, risk controls, verification and validation activities, and final product requirements.

• Support regulatory submissions by preparing and reviewing risk management documentation that demonstrates compliance and sound risk‑based decision‑making.

• Contribute to post‑market surveillance activities, including complaint analysis, CAPA investigations, and updates to risk management files based on field performance and feedback.

• Drive continuous improvement of risk management processes, tools, and templates to enhance efficiency, consistency, and regulatory alignment.

• Provide training and mentorship to engineering and cross‑functional teams on risk management best practices, tools, and methodologies.

Essential Skills

• Bachelors degree in Engineering, such as Mechanical, Biomedical, Electrical, or a closely related field.

• 35 years of experience in medical device design quality, design assurance, or risk management.

• Strong working knowledge of ISO‑based risk management standards and QSR/21 CFR Part 820 requirements for medical devices.

• Hands‑on experience creating and maintaining risk management files for Class I, II, or III medical devices.

• Proficiency with risk analysis tools, including DFMEA, PFMEA, fault tree analysis (FTA), and hazard analysis.

• Experience supporting design controls and product development processes within a regulated medical device environment.

• Excellent written and verbal communication skills, with the ability to influence and guide engineering teams and cross‑functional stakeholders.

• Strong analytical and problem‑solving abilities, with a structured and detail‑oriented approach to risk assessment and mitigation.

Additional Skills & Qualifications

• Experience participating in or supporting Notified Body audits or FDA inspections related to medical device products.

• Risk management certification, such as ISO lead auditor or lead implementer, is a plus.

• backgrnd in medical device quality engineering and quality systems is beneficial.

• Demonstrated ability to drive continuous improvement initiatives in risk management processes and tools.

• Experience providing training or mentorship on risk management practices within engineering or quality teams.

Work Environment

The role operates within a highly regulated medical device development and manufacturing environment that emphasizes patient safety, product reliability, and strict adherence to quality and regulatory standards. The Design Quality Engineer works closely with cross‑functional teams, including R&D, Regulatory Affairs, Manufacturing, and Quality Systems, in a collaborative setting that values structured problem‑solving, data‑driven decision‑making, and thorough documentation. The position typically involves standard business hours with occasional flexibility to support project milestones, design reviews, audits, or regulatory submissions. The work is primarily office‑based, with regular interaction with engineering labs and production areas as needed to support design controls and risk management activities. The culture encourages continuous improvement, professional development, and knowledge sharing, creating an environment where quality and compliance are integral to everyday work.

Job Type & Location

This is a Contract position based out of Fremont, CA.

Pay and Benefits

The pay range for this position is $60.10 - $67.31/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job‑related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre‑tax and Roth post‑tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long‑term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 16, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News‑Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.