R&D Engineer

This is a remote position.

We are seeking a talented and self-driven R&D Engineer to support the design, development, and optimization of innovative medical devices and life sciences systems. This role requires a balance of technical expertise, creativity, and regulatory discipline transforming clinical and user requirements into safe, functional, and compliant product designs. The ideal candidate combines strong engineering fundamentals with an understanding of FDA, ISO 13485, and ISO 14971 requirements, collaborating with cross-functional teams to deliver high-quality, manufacturable, and regulatory-compliant medical technologies that improve patient [link removed] ResponsibilitiesLead and contribute to the end-to-end product development lifecycle, from concept and feasibility to design transfer and [link removed] 3D models, detailed drawings, and engineering documentation using CAD software (e.g., SolidWorks, Creo) to support mechanical and electromechanical device [link removed] design verification and validation (V&V) testing, analyze data, and generate technical reports that demonstrate compliance with applicable standards and [link removed] with Quality, Regulatory, Manufacturing, and Clinical teams to ensure design activities align with Design Control (21 CFR 820.30) and risk management standards (ISO 14971).Participate in risk analyses (FMEA, DFMEA, PFMEA), hazard assessments, and mitigation strategies throughout the product [link removed] prototype fabrication, bench testing, and design iteration, translating test results into actionable design [link removed] with Manufacturing Engineering to ensure Design for Manufacturability (DFM), Design for Assembly (DFA), and process validation (IQ/OQ/PQ) [link removed] and maintain Design History File (DHF) documentation and ensure compliance with ISO 13485 quality system [link removed] the design transfer process, including pilot builds, process validations, and technical documentation for production [link removed] to continuous improvement initiatives, applying statistical methods, Lean, and Six Sigma principles to enhance design efficiency and product [link removed]-Have Qualifications:Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related technical [link removed] experience in medical device product development, including exposure to design controls, risk management, and [link removed] proficiency with CAD tools (e.g., SolidWorks, Creo, or equivalent) and engineering documentation [link removed] knowledge of FDA Design Control (21 CFR 820), ISO 13485, and ISO [link removed] ability to execute V&V testing, data analysis, and root cause [link removed] technical writing and documentation skills with attention to regulatory [link removed] collaboration and communication skills with cross-functional project [link removed] Qualifications:Experience developing electromechanical systems, implantable devices, or disposable medical [link removed] with materials selection, sterilization validation, and biocompatibility [link removed] to process development, design transfer, and manufacturing [link removed] in finite element analysis (FEA) or tolerance stack-up [link removed] of ISO 60601, IEC 62304, or EU MDR [link removed] working in Agile or phase-gated product development [link removed] in Lean Six Sigma, ASQ CQE, or PMP is a plus.This is intended for inclusion in Pharmavise’s talent database to build a qualified pool of professionals for future medical device client requisitions.

Originally posted on Himalayas