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 outcomes.
Key Responsibilities
Lead and contribute to the end-to-end product development lifecycle, from concept and feasibility to design transfer and commercialization.
Develop 3D models, detailed drawings, and engineering documentation using CAD software (e.g., SolidWorks, Creo) to support mechanical and electromechanical device design.
Conduct design verification and validation (V&V) testing, analyze data, and generate technical reports that demonstrate compliance with applicable standards and requirements.
Collaborate 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 lifecycle.
Support prototype fabrication, bench testing, and design iteration, translating test results into actionable design improvements.
Work with Manufacturing Engineering to ensure Design for Manufacturability (DFM), Design for Assembly (DFA), and process validation (IQ/OQ/PQ) readiness.
Prepare and maintain Design History File (DHF) documentation and ensure compliance with ISO 13485 quality system requirements.
Support the design transfer process, including pilot builds, process validations, and technical documentation for production release.
Contribute to continuous improvement initiatives, applying statistical methods, Lean, and Six Sigma principles to enhance design efficiency and product quality.
Must-Have Qualifications:
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related technical field.
Professional experience in medical device product development, including exposure to design controls, risk management, and validation.
Strong proficiency with CAD tools (e.g., SolidWorks, Creo, or equivalent) and engineering documentation practices.
Working knowledge of FDA Design Control (21 CFR 820), ISO 13485, and ISO 14971.
Demonstrated ability to execute V&V testing, data analysis, and root cause investigations.
Excellent technical writing and documentation skills with attention to regulatory compliance.
Strong collaboration and communication skills with cross-functional project teams.
Preferred Qualifications:
Experience developing electromechanical systems, implantable devices, or disposable medical products.
Familiarity with materials selection, sterilization validation, and biocompatibility testing.
Exposure to process development, design transfer, and manufacturing scale-up.
Proficiency in finite element analysis (FEA) or tolerance stack-up analysis.
Knowledge of ISO 60601, IEC 62304, or EU MDR requirements.
Experience working in Agile or phase-gated product development environments.
Certification 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.
