Job Description
Senior Mechanical Engineer
• Strong proficiency in 3D CAD software (e.g., SolidWorks, Creo, or AutoCAD) and experience with finite element analysis (FEA) tools.
• Experience working with vendor partners on R&D; projects, assisting in performance tracking, SLA monitoring, and supporting demand planning to ensure alignment with project requirements.
• Familiarity with medical device product lifecycle management, with experience in applying FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC60601), ensuring compliance with project-specific regulations.
• Experience in supporting project and program management efforts, with a focus on managing day-to-day vendor partner interactions, driving continuous improvement in engineering processes, and contributing to team growth.
• Comfortable working in Agile SCRUM and stage-gate environments, ensuring collaboration with cross-functional teams to meet project objectives.
• Ability to develop and contribute to design documentation, including CAD models, specifications, and compliance records for manufacturability and quality assurance.
• Knowledge of materials compatibility, durability testing, and mechanical design principles, contributing to design solutions to mitigate risks.
• Understanding of manufacturing processes for mechanical components, including injection molding, machining, and rapid prototyping, and experience with managing design for manufacturability.
• Experience with requirements management systems (e.g., DOORS,



JAMA), contributing to risk analysis and DFMEA processes in mechanical R&D; projects.
• Effective stakeholder management skills, collaborating with PMO teams to ensure technical alignment and timely project delivery.
• Experience working with project data, contributing to technical assessments and identifying opportunities for process improvements and operational efficiency.
• Strong communication skills, with the ability to present technical updates and information clearly to cross-functional teams and stakeholders. Education
• A degree or higher qualification in Biomedical / Mechanical Engineering from a recognized university.
• Masters in biomedical / Mechanical engineering or business will be an added advantage. Experience
• 6-10 years of experience in Mechanical Engineering R&D; in the medical devices domain, with a strong technical knowledge.
• Proven experience in collaborating with PMOs and global teams on mechanical projects.
• Strong technical background in mechanical design, circuit board development, and compliance with regulatory standards.
• Experience with design for manufacturability (DFM) and design for assembly (DFA) principles.
• Experience in medical device development. Required Skills
• Robust technical expertise in mechanical engineering, materials science, and product design, with hands-on experience in R&D; and/or sustaining engineering, especially in product development environments.

📌 Senior Mechanical Engineer (Hyderabad)
🏢 SolidPro - HelixA
📍 Hyderabad