**Client:** Confidential (Dental Industry) **Role:** Design Controls Engineer **Alternative Titles:** Quality Engineer – Design / Design Quality Engineer / Product Development Quality Engineer / Design Engineer **Location:** LATAM – 100% Remote **Contract Type:** Contractor **Duration:** 6 months with potential extension **Equipment:** Laptop provided **About Us** Our company is transforming dental manufacturing by combining digital design, automation, and quality systems to deliver precision restorations at scale. We are ISO 13485 certified and rapidly expanding across multiple sites. To sustain compliance and close design\-related gaps, we are seeking a Design Controls Engineer to own ISO\-required design processes across the organization. **About the Role** As a Design Controls Engineer, you will ensure all activities related to design controls, risk management, verification/validation, and design transfer comply with ISO 13485, FDA 21 CFR 820, and MDSAP. Design activities are distributed across operations, digital design, and product teams, and this role will act as the central owner of design compliance, bridging these functions into our QMS. **Responsibilities** * Establish and maintain Design \& Development procedures (ISO 13485 §7\.3\), including templates for Design Plans, Inputs/Outputs, Reviews, and Design History Files (DHFs) for hardware and software. * Lead cross\-functional design reviews across hardware, software, and materials; integrate risk, validation, and change control. * Develop and maintain DHFs, Device Master Records (DMRs), and Master Device Files (MDFs) for scanner systems, inks, and digital design software. * Drive risk management per ISO 14971, integrating hazard analysis, FMEAs, and risk traceability. * Author and review verification/validation protocols and reports, including equipment qualifications (IQ/OQ/PQ), material validation, and software lifecycle documentation (IEC 62304\). * Establish design transfer protocols linking development to manufacturing, ensuring traceability through BOMs, DHRs, and process validation. * Coach internal teams on design control expectations for SaMD (software as a medical device) and hardware. * Support audits and submissions, providing SME input on design controls, risk management, and technical files. * Implement document and record management structures for all design records in the QMS (Dot Compliance). **Requirements** * 5\+ years of experience in medical device, dental device, or life sciences industries with a focus on design controls, new product development, and process validation. * Proven experience building design control frameworks from scratch (startups or greenfield environments preferred). * Deep knowledge of ISO 13485, FDA 21 CFR 820, MDSAP, ISO 14971, and IEC 62304\. * Strong experience with hardware and material design verification (scanner systems, inks, or similar digital manufacturing devices). * Experience leading design and risk reviews, authoring DHFs, RMFs, and validation documentation. * Experience with SaMD classification, validation, and regulatory documentation. * Excellent organizational and communication skills; able to bridge quality, engineering, and product teams effectively. * Certifications such as ASQ CQE/CQA, Six Sigma Black Belt, or ISO 13485 Lead Auditor are preferred. Job Types: Full\-time, Contract Contract length: 12 months Application Question(s): * Given that this role is remote and we operate as contractors (payment in USD), are you able to work remotely? What is your salary expectation in USD per month? * Have you authored or maintained DHFs, RMFs, or validation protocols for hardware/software? * Have you implemented ISO 13485 design controls and worked with FDA 21 CFR 820 or MDSAP? * Do you have experience with ISO 14971, FMEAs, and verification/validation activities (IQ/OQ/PQ, software lifecycle) * Do you have experience in medical/dental device or life sciences design controls, ideally in startups or greenfield projects? How many years?