Design Quality Engineer

Design Quality Engineer

The Design Quality Engineer plays a critical role in ensuring robust and compliant design control practices for sustaining engineering activities. This position acts as a quality representative on cross-functional teams to support compliance with regulatory requirements, including 21 CFR 820 and EU MDR, while also maintaining internal quality standards. The Design Quality Engineer collaborates with various departments such as Legal, Manufacturing Operations, and Operations Transfer partners to ensure compliant development and product/process transitions. The role involves supporting design changes, risk management activities, quality documentation, complaint investigations, and continuous improvement throughout the product lifecycle.

Responsibilities:

• Support design verification and validation, risk management, and design reviews to ensure product safety, performance, and regulatory requirements are met.
• Review engineering design changes and provide quality input on documentation, traceability, and risk assessment; support continuous improvement of design processes, templates, and procedures.
• Provide quality support for sustaining engineering projects, product improvements, and Operations Transfer activities, including transfer of products and processes into manufacturing and supplier environments.
• Assist with quality deliverables for regulatory submissions, including 510k technical documentation and IDE-related documentation; support audits, quality metrics, management review inputs, and other quality-related duties assigned by management.

Essential Skills:

• Working knowledge of 21 CFR 820 and EU MDR.
• Experience with Design Controls and risk management, particularly related to electronic device design.
• Statistical knowledge, including understanding of measurement uncertainty and experience with statistical analysis and techniques.
• Detail-oriented and well organized with excellent communication skills.
• Ability to accomplish objectives with general supervision and escalate issues appropriately.
• Application of scientific principles and problem-solving, scientific rationale, and technical logic to engineering activities and development decisions.
• Advanced Excel skills, including data analysis and reporting.
• Advanced English communication skills, both written and verbal.

Additional Skills & Qualifications:

• A bachelor’s degree or higher in an engineering field such as electrical, systems, mechanical, or biomedical engineering.
• Minimum of 2 years experience in design, sustaining engineering, or medical device quality engineering.
• Knowledge of basic regulations applicable to manufacturing in the United States, regulatory requirements, product registrations, compliance activities, and audit processes.

Work Environment:

The position involves collaboration with various teams, including Engineering, Legal, Manufacturing Operations, and Operations Transfer teams. The role requires working on design changes to existing products, supporting development workflows, and facilitating product/process transfers into manufacturing and supplier environments. The work environment demands advanced Excel skills for data analysis and reporting, and excellent English communication skills for both written and verbal interactions.

Job Type & Location:

This is a Contract position based out of Warsaw, IN.

Pay and Benefits:

The pay range for this position is $38.00 - $44.00/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)

Application Deadline:

This position is anticipated to close on Nov 21, 2026.

Workplace Type:

This is a fully onsite position in Warsaw, IN.

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 View email address on click.appcast.io 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.