Design Quality Engineer

Job Title: Design Quality EngineerJob DescriptionThe Design Quality Engineer serves as a highly engaged quality partner to research and development teams across new product development and sustaining engineering activities for the iovera product line. This fully remote role collaborates closely with globally distributed R&D, Quality, Regulatory, Operations, and other cross-functional teams. While R&D retains ownership of the design and technical deliverables, the Design Quality Engineer provides independent design quality guidance and review to help teams navigate design control requirements and produce robust, compliant Design History File (DHF) documentation. The position focuses on design controls, design verification and validation, risk management, requirements traceability, design changes, and lifecycle quality activities in accordance with applicable regulatory requirements and internal quality standards.

Responsibilities

• Partner closely with R&D and cross-functional teams throughout new product development and sustaining engineering activities, providing proactive design quality guidance while maintaining R&D ownership of the design and associated technical deliverables.
• Guide teams through design control requirements and review Design History File (DHF) deliverables for completeness, consistency, traceability, and compliance throughout the product lifecycle.
• Review design inputs and outputs to ensure requirements are clear, measurable, testable, traceable, and appropriately linked to user needs, regulatory requirements, risk controls, and applicable standards.
• Provide hands-on quality review of design verification and validation plans, protocols, and reports, including assessment of test strategy, test methods, sample size and statistical rationale, acceptance criteria, deviations, objective evidence, results, and conclusions.
• Support and participate in formal design reviews as the independent quality representative, identifying gaps and helping R&D determine appropriate actions before progression to subsequent development phases.
• Support risk management activities, including hazard analyses and related risk assessments, and help ensure identified risk controls are appropriately translated into design requirements and verified or validated with objective evidence.
• Review engineering design changes and sustaining activities to assess affected requirements, risk impact, verification and validation needs, traceability, documentation, and other applicable design control considerations.
• Support design validation and usability/human factors activities, as applicable, including evaluation under actual or simulated use conditions and alignment of validation evidence with intended users, use environments, and intended use.
• Support design transfer by reviewing applicable specifications, drawings, test and inspection methods, manufacturing requirements, supplier requirements, and transfer evidence to help ensure design outputs are suitable for production.
• Review supplier or external laboratory-generated technical evidence used for design verification or validation, including test plans, reports, product identification, traceability, and acceptance criteria, as applicable.
• Use complaint, nonconformance, corrective and preventive action (CAPA), and post-market information as inputs to sustaining design, risk management, and continuous improvement activities, identifying design-related trends or failure modes requiring evaluation.

Essential Skills

• BS degree or higher in an engineering or related technical field such as Electrical, Systems, Mechanical, or Biomedical Engineering.
• Minimum 3 years of relevant medical device experience, including hands-on work with design controls, DHF documentation, and new product development and/or sustaining engineering.
• Demonstrated experience reviewing or developing design verification and validation plans, protocols, and reports, including requirements traceability, acceptance criteria, test methods, sample-size and statistical rationale, deviations, and conclusions.
• Fluent professional proficiency in English (spoken, written, and reading comprehension), with the ability to independently interpret, review, and author complex technical and quality documentation.
• Ability to communicate effectively with global cross-functional teams and produce high-quality DHF documentation, design-control records, risk-management documentation, and verification and validation protocols and reports.
• Working knowledge of medical device design control and quality system requirements, including ISO standards, 21 CFR Part 820 / FDA Quality Management System Regulation, and EU MDR.
• Practical experience with DHF execution, design inputs and outputs, requirements traceability, formal design reviews, design changes, design transfer, and risk management.
• Ability to critically review verification and validation strategies and objective evidence and provide clear, risk-based guidance without assuming ownership of R&D technical deliverables.
• Working knowledge of statistical methods used in verification and validation, including sample-size rationale, confidence and reliability concepts, measurement systems, and measurement uncertainty.
• Strong attention to detail, excellent organizational skills, and the ability to collaborate effectively in a remote, cross-functional environment.

Additional Skills & Qualifications

• Experience working with ISO 14971 or similar risk management standards for medical devices.
• Background in medical device development environments with global teams and cross-functional collaboration.
• Comfort working with complex technical documentation and regulatory requirements across the product lifecycle.
• Ability to influence and guide teams through quality and regulatory expectations while supporting innovation and timely project execution.

Work EnvironmentThis role operates in a 100% remote work environment, collaborating with globally distributed R&D, Quality, Regulatory, Operations, and other cross-functional teams. Work is performed using typical office and collaboration technologies suitable for remote engineering and quality activities, with extensive use of electronic documentation, virtual meetings, and shared digital platforms. The position requires effective communication across time zones and the ability to manage responsibilities independently while remaining closely aligned with project teams and organizational quality standards. Job Type & LocationThis is a Contract position based out of Warsaw, IN. Pay and BenefitsThe pay range for this position is $45.00 - $54.00/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) Job Type & LocationThis is a Contract position based out of Warsaw, IN. Application DeadlineThis position is anticipated to close on Nov 14, 2026. Workplace TypeThis is a fully remote position.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.

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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.

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Use of Artificial Intelligence (AI):

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