Design Quality Engineer

Job Title:

Design Quality Engineer Job Description As a Design Quality Engineer, you will support risk management activities in accordance with ISO standards, focusing on the identification, analysis, mitigation, and documentation of risks throughout the design lifecycle. You will also support the development of Use, Design, and Failure Modes and Effects Analysis (FMEA) to ensure that potential failure modes are systematically identified and addressed with appropriate risk controls. Responsibilities Support design verification and validation activities, including the development, review, and approval of test plans, protocols, and reports, with a focus on compliance testing for biocompatible, sterile, single-use consumable products. Develop and maintain the Usability Engineering File in accordance with IEC standards and applicable regulatory requirements. Support supplier qualification and process validation activities by reviewing supplier documentation and quality outputs. Evaluate test and inspection equipment, develop methods, and conduct qualification activities as required. Assist with manufacturing transfer activities, including the creation and review of DMR/DHR documentation and the execution or review of validation protocols (IQ, OQ, PQ). Develop, review, and maintain work instructions, manufacturing procedures, and inspection documentation to ensure alignment with validated processes and design. Lead and support risk management activities per ISO standards using a system-level, top-down, and bottom-up approach. Ensure risk controls are implemented and verified, and residual risk is supported by objective evidence. Support tolerance, worst-case, and margin analyses as inputs to risk assessment and verification planning. Provide Quality oversight of design verification and validation (V&V) planning, execution, and reporting. Review and approve V&V protocols and reports to ensure adequate coverage of requirements, risks, and regulatory expectations. Collaborate with Software Quality and Systems Engineering to ensure HW/SW integration risks are addressed. Essential Skills Bachelor's degree in Engineering, Biomedical Engineering, or Life Sciences. 5-7 years of experience as a Quality Engineer or Design Quality Engineer in the medical device industry, supporting development and sustaining activities for sterile, single-use consumables and packaging. Hands-on experience with

ISO 10993-1, ISO

13485, and

ISO 14971

preferred. Working knowledge of

QMSR, ISO 14971, IEC

62366, and MDD/MDR requirements. Experience in IEC 60601 and SWFMEA development is required. Additional Skills & Qualifications Experience with electromechanical and single-use consumables. Proficiency in risk management, new product development, FMEA, and validation. Strong skills in root cause analysis and validation. Work Environment The work environment involves compliance testing and validation activities for biocompatible, sterile, single-use consumable products. The position requires collaboration with cross-functional teams and adherence to regulatory standards in a professional engineering setting. Job Type & Location This is a Contract position based out of Newton, MA. Pay and Benefits The pay range for this position is $45.00 - $56.48/hr. 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 onsite position in Newton,MA.

Application Deadline This position is anticipated to close on Mar 4, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. 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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.