Jobs at DEKA Research & Development

The PCB Layout Designer will translate electrical schematics into optimized PCB layouts, collaborating with engineers, ensuring design integrity, and managing the workflow for manufacturing.

The Project Manager will oversee post market surveillance activities, ensuring compliance with regulations, managing risks, and facilitating cross-functional collaboration.

As a Product Development Automation Engineer at DEKA, you will specify, design, validate, and support automated manufacturing equipment while ensuring effective communication with engineering, operations, and quality departments.

Review and evaluate medical device complaints, ensure documentation meets QMS and FDA requirements, determine regulatory reporting, coordinate with manufacturers and teams, support audits and CAPA, generate improvement reports, and develop training aids under manager supervision.

Provide executive and administrative support to senior leadership: manage calendars, travel, expenses, meeting logistics, and correspondence. Maintain records and filing systems. Coordinate project plans, deadlines, and follow-up across teams and external partners to ensure commitments are tracked and completed. Anticipate leadership needs and handle urgent requests as required.

Manage end-to-end CAPA process, lead cross-functional reviews, maintain CAPA documentation and SOPs, ensure FDA 21 CFR Part 820 and ISO 13485 compliance, monitor quality metrics, conduct internal and support external audits, and drive QMS continuous improvement and training.

Coordinate projects, manage schedules, meetings, travel, and administrative tasks; perform market, customer, competitor, and financial research; develop commercialization plans and executive presentations; own high-priority ambiguous projects, identify roadblocks, and drive solutions to completion.

Investigate returned medical devices to determine root cause through log review, physical evaluation, and data acquisition. Document findings in an FDA-compliant QMS, support corrective actions, maintain procedures, and collaborate with engineering teams to improve product quality.

The Senior Supplier Quality Engineer leads supplier quality activities for NPI and sustaining operations, ensuring compliance, conducting audits, and monitoring supplier performance through quality metrics. This role collaborates with cross-functional teams, drives corrective actions, and supports continuous improvement initiatives.

The Supplier Quality Engineer oversees supplier quality activities for new product introductions and sustaining manufacturing in a regulated environment, ensuring compliance with quality standards and managing supplier performance.

Lead and oversee post market surveillance activities for medical devices, ensuring compliance with regulations and quality management, while mentoring a multidisciplinary team.

Review and evaluate medical device complaints, ensure complaint documentation and reporting meet FDA and QMS requirements, lead investigations and root-cause analysis, interface with vendors and regulatory agencies, support audits/CAPA, generate process-improvement reports, and develop training aids.

Lead software quality assurance for medical device development: capture requirements, develop system-level test strategies and protocols, perform hazards and failure-modes analyses, support/configure validated software tools, and guide device teams on regulatory software validation.

Design and implement scalable backend services and distributed, event-driven data pipelines. Build, deploy, and monitor production ML models (feature engineering through deployment). Integrate ML models with rule-based decision engines and contribute to AI/LLM-driven orchestration. Collaborate across engineering, data, and product teams to deliver reliable, production-grade systems.

Embed with cloud engineering teams to create and maintain IEC 62304-compliant software lifecycle documentation (SDP, SRS, SDD, V&V plans/reports, risk files), drive document change control and traceability, author SOPs and templates, coordinate documentation project plans and readiness reviews, and champion automation-first DevSecOps quality practices to keep releases audit-ready.