R&D Engineer

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October 23

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Pharmavise Corporation

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Pharmavise Corporation is the first Continuous Compliance Organization (CCO) dedicated to maintaining the highest standards of quality and regulatory compliance in the life sciences industry. Our esteemed client base includes Fortune 500 companies in pharmaceuticals, medical devices, and biotechnology. We offer bespoke solutions tailored to meet the specific compliance needs of our clients, supporting them from development through commercialization and ensuring they exceed their compliance goals while enhancing patient health and safety.

11 - 50 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• N/A