Job Description

Interested candidates may apply by sharing their updated CV at

hrd@larsmedicare.com or WhatsApp it to +91 8930111001

Key Responsibilities:

Lead the complete product design lifecycle, including concept development, feasibility assessment, detailed design, verification, validation, and product launch Translate customer, clinical, business, and regulatory requirements into clear and effective design inputs and engineering solutions Drive and govern design control processes in compliance with ISO 13485, GMP, and applicable regulatory guidelines Own and maintain Design History Files (DHF), technical documentation, design reviews, and change management records Lead risk management activities, including hazard analysis and FMEA. Plan, conduct, and chair design reviews to ensure design maturity, traceability, and risk mitigation Collaborate closely with Production, QA, PPC, Purchase, and Regulatory teams to ensure seamless design transfer to manufacturing Support validation builds, pilot runs, and issue resolution during scale-up and commercialization Evaluate and implement new technologies, design approaches, and improvement opportunities to enhance performance, quality, and cost-effectiveness Build, mentor, and lead a high-performing design team while fostering a culture of accountability, innovation, and continuous improvement Address customer feedback, complaints, deviations, and CAPA related to design and product performance Ensure audit readiness and actively support internal, customer, and regulatory audits

Education

B.E./B.Tech / M.E./M.Tech in Mechanical, Biomedical, Electronics, or Design Engineering

Experience

10-12 years of progressive experience in medical device design & development Proven experience in leading design teams and managing multiple projects in a regulated environment

Skills & Competencies

Strong understanding of medical device design controls and regulatory expectations Hands-on expertise with CAD tools such as SolidWorks, AutoCAD, or equivalent Excellent knowledge of product lifecycle documentation and controlled development processes Ability to balance innovation with compliance, manufacturability, timelines, and cost Strong project planning, analytical, and decision-making skills Effective communicator with the ability to influence and collaborate across functions People-centric leader with strong coaching, mentoring, and team-building capabilities
Job Type: Full-time

Pay: ?80,000.00 - ?100,000.00 per month

Work Location: In person