Jobs at DEKA Research & Development

Designs multilayer printed circuit board layouts from schematics, including component placement, high-speed routing, signal integrity, power distribution, and design-rule validation. Maintains symbols, footprints, and 3D component models while supporting documentation, fabrication, assembly, and revision control. Collaborates with electrical and mechanical engineers and manufacturing partners to optimize designs for performance, compliance, manufacturability, and cost.

Supports commercialization and business strategy for emerging technologies and new products. Responsibilities include market and competitive research, partner and customer identification, executive presentations, business plans, go-to-market strategies, financial modeling, and strategic outreach. The role works closely with senior leadership and external stakeholders to evaluate opportunities, develop recommendations, and advance initiatives across product strategy, partnerships, investment, and new business development.

Manages quality system documents, records, document change notifications, training, and electronic quality management system processes in a regulated medical device R&D environment. Reviews quality records, maintains controlled documentation, tracks training and action items, monitors process metrics, supports eQMS implementation and audits, and provides QMS training and awareness across the organization. Requires knowledge of ISO 13485 and quality system regulations, regulated documentation experience, strong communication, and proficiency with office software.

Design and implement scalable backend services, microservices, distributed streaming pipelines, and production machine learning models. Own the ML lifecycle from feature engineering and training through deployment, evaluation, and monitoring. Integrate ML models with rule-based decision engines, contribute to AI/LLM workflows, and collaborate across engineering, data, and product teams to deliver reliable systems.

Reviews and investigates medical device complaints, determines regulatory reportability, documents findings, and drives records to closure under QMS and FDA requirements. The role interfaces with manufacturers, healthcare professionals, regulatory agencies, and internal teams; supports audits and CAPA investigations; coordinates forensic product investigations; generates process-improvement reports; develops training aids; and serves as a complaint-handling subject matter expert.

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.

Own the end-to-end CAPA process, including investigations, root cause analysis, corrective actions, effectiveness verification, documentation, and trend monitoring. Develop SOPs and change controls, maintain QMS compliance with FDA 21 CFR Part 820 and ISO 13485, review quality records, conduct internal audits, and support FDA, ISO, and customer audits. The role also provides training, technical writing, project coordination, and continuous improvement support.

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.

Review and evaluate medical device complaints, ensure documentation and QMS compliance with FDA regulations, determine regulatory reporting, support investigations and audits, interface with manufacturers and healthcare professionals, generate improvement reports, and develop training aids.

Lead cross-functional teams to invent, design, develop, validate, and commercialize electromechanical medical devices with embedded software. Translate high-level goals into system requirements, create comprehensive project plans, and manage schedule, budget, resources, and stakeholder relationships through design, V&V, clinical trials, and transfer to manufacturing.

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.