Gandiv Insights LLC · 9 hours ago
New Product Development Engineer
Houston, TX
Contract
Onsite
Mid, Senior Level
3+ years expGandiv Insights LLC is focused on the development of innovative medical device products, and they are seeking a New Product Development Engineer to drive the design and commercialization of these products. This role involves working cross-functionally to ensure compliance and successful project deliverables from concept to market.
Information Technology & Services
Responsibilities
Support full product lifecycle from concept, feasibility, design, verification/validation (V&V), transfer, and launch
Develop design inputs, risk assessments, and design outputs in compliance with ISO 13485 and 21 CFR 820 design controls
Partner with cross-functional teams (R&D, Quality, Regulatory, Supplier, Manufacturing) to ensure project deliverables
Execute Design Verification & Validation activities including test protocols, reports, and design reviews
Work with manufacturing engineers to support Design for Manufacturability (DFM) and process development
Support Risk Management activities per ISO 14971 including pFMEA/dFMEA documentation
Prepare technical documentation for DHF (Design History File), DMR (Device Master Record), and Change Control
Collaborate with Regulatory Affairs to support 510(k), PMA, or global submissions
Facilitate product testing including biocompatibility, packaging & sterilization validations when required
Support supplier selection, component qualification, and cost reduction initiatives
Participate in design reviews, root cause analysis, and CAPA investigations for design-related issues
Qualification
Required
Bachelor's or Master's degree in Mechanical, Biomedical, Electrical, or related engineering discipline
3+ years of experience in Medical Device NPD, R&D, Product Development, or related engineering
Experience with Design Controls (21 CFR Part 820) and ISO 13485 QMS
Knowledge of SolidWorks, Creo, or other CAD modeling tools
Experience with test method development and V&V execution
Strong documentation, technical writing, and communication skills
Preferred
Experience with disposable or electromechanical medical devices
Familiarity with Risk Management (ISO 14971)
Understanding of sterilization, packaging validation, and biocompatibility
Familiarity with regulatory submissions (510k preferred)
Experience with DHF/DMR and Change Control processes (Agile, Arena, Windchill, etc.)
Company
Gandiv Insights LLC
Gandiv Insights is a leading professional services and staffing firm specializing in top-tier personnel and technical solutions across engineering, IT, non-IT, and healthcare sectors.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase