The Design Quality Engineer will serve as a highly engaged Quality partner to R&D across new product development and sustaining engineering activities for the iovera product line. This is a remote position that will collaborate closely with globally distributed R&D, Quality, Regulatory, Operations, and other cross-functional teams. R&D remains the owner of the design, design decisions, and design deliverables; this role provides independent Design Quality guidance and review to help the team navigate design control requirements and produce robust, compliant Design History File (DHF) documentation. The role will focus on design controls, design verification and validation, risk management, requirements traceability, design changes, and lifecycle quality activities in accordance with applicable regulatory requirements (e.g., 21 CFR 820, ISO 13485, EU MDR) and internal quality standards.
Essential Duties & Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.
· 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 DHF deliverables for completeness, consistency, traceability, and compliance throughout the product lifecycle.
· Review design inputs and outputs to help 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 test strategy, test methods, sample size/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 FMEAs, 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/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, CAPA, and post-market information as inputs to sustaining design, risk management, and continuous improvement activities; identify design-related trends or failure modes requiring evaluation.
· Collaborate with Regulatory Affairs, Operations, Manufacturing, Quality Assurance, suppliers, and other functions in a fully remote, globally distributed work environment; support audi
Skills: ts and regulatory submissions by providing or reviewing applicable design control and risk management documentation. Supervisory Responsibilities: This role does not have supervisory responsibilities. Interaction: The incumbent works closely with R&D as a Design Quality partner and independent reviewer while collaborating remotely with Quality Assurance, Regulatory Affairs, Operations, Manufacturing, suppliers, test laboratories, and other cross-functional stakeholders across locations and time zones. R&D remains accountable for design ownership and technical deliverables; this role provides guidance, review, and quality oversight to support compliant execution. The incumbent must be able to communicate effectively and work independently in a remote environment while maintaining strong cross-functional engagement. Education and Experience: · BS Degree or higher in an engineering or related technical field required (e.g., Electrical, Systems, Mechanical, Biomedical Engineering). · Minimum 3 years of relevant medical device experience, including meaningful hands-on experience 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/statistical rationale, deviations, and conclusions. · Fluent professional proficiency in English (spoken, written, and reading comprehension), with demonstrated ability to independently interpret, review, and author complex technical and quality documentation and communicate effectively with global cross-functional teams. This includes Design History File (DHF) documentation, design-control records, risk-management documentation, and verification and validation protocols and reports. Knowledge, Skills, and Abilities: · Working knowledge of medical device design control and quality system requirements, including ISO 13485, 21 CFR Part 820 / FDA Quality Management System Regulation, and EU MDR. · Practical experience with DHF execution, design inputs/outputs, requirements traceability, formal design reviews, design changes, design transfer, and risk management; working knowledge of ISO 14971 preferred. · 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/reliability concepts, measurement systems, and measurement uncertainty. · Detail oriented, well organized, collaborative, and able to communicate technical and quality expectations effectively in a remote, cross-functional environment; able to work independently with general supervision, manage priorities across multiple projects, appropriately challenge gaps, and escalate significant issues when needed. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Duties of this job are performed in a fully remote work environment and primarily involve sitting for extended periods, daily computer and keyboard use, participation in virtual meetings, and frequent review and preparation of electronic technical documentation. Close vision and the ability to focus on a computer screen and use a keyboard and mouse are required. The role does not require travel or routine attendance at a company office or other onsite location. Work Environment: The work environment characteristi
Education: cs described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. This position is fully remote and is performed from a remote/home-office setting. The work involves frequent computer-based activity, virtual meetings, and collaboration with team members across locations and time zones. The employee is expected to maintain a professional remote workspace suitable for confidential discussions, electronic document review, and reliable virtual collaboration. Travel and routine onsite or office attendance are not required for this role.
