Senior R&D Engineer

Job Title: R&D Engineer Supervisor/ Assistant Manager – R&D

Job Summary:

The R&D Engineer Supervisor leads a team of engineers and technicians in the design, development, and improvement of medical devices from concept through commercialization. This role ensures that all R&D activities align with regulatory requirements (e.g., FDA, ISO 13485), quality standards, and company objectives. The supervisor provides technical guidance, manages project timelines, and fosters innovation within the product development team.

Key Responsibilities:

1. Leadership & Supervision

• Supervise and mentor a multidisciplinary team of R&D engineers and technicians.
• Assign tasks, set priorities, and monitor progress on multiple concurrent projects.
• Foster a collaborative, high-performance team environment focused on innovation and quality.

2. Product Development

• Oversee the design and development of new medical devices and improvements to existing products.
• Ensure design control compliance, including risk management, verification/validation, and design transfer activities.
• Collaborate with cross-functional teams (Quality, Regulatory, Manufacturing, Marketing, Clinical) throughout the product lifecycle.

3. Technical Expertise

• Provide hands-on technical support for prototyping, testing, and troubleshooting.
• Review and approve engineering documentation (design inputs/outputs, test protocols, reports, drawings, specifications).
• Support root cause analysis and implementation of design changes as needed.

4. Regulatory & Quality Compliance

• Ensure R&D activities comply with FDA, ISO 13485, MDR, and other applicable standards.
• Participate in design reviews, risk assessments (ISO 14971), and audits.
• Support preparation of technical documentation for regulatory submissions.

5. Project Management

• Plan and track R&D project schedules, budgets, and resource allocation.
• Identify risks and implement mitigation strategies to meet project milestones.
• Report project status and performance metrics to senior management.

6. Continuous Improvement

• Drive innovation and process improvement within the R&D department.
• Stay current with emerging technologies, materials, and regulatory trends in the medical device industry.

Qualifications:

Education:

• Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or related field.
• Advanced degree preferred.

Experience:

• 3 -5 years of R&D experience in the medical device industry, including at least 2 years in a supervisory or leadership role.
• Proven experience in product design, development, and verification/validation under design control.
• Familiarity with regulatory and quality requirements (FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, etc.).

Skills & Competencies:

• Strong leadership and team management abilities.
• Excellent project management, problem-solving, and analytical skills.
• Proficiency with CAD tools and engineering documentation systems.
• Effective communication and cross-functional collaboration skills.
• Innovative mindset with a focus on patient safety and product quality.

Job Type: Full-time

Pay: ₹30,000.00 - ₹40,000.00 per month

Benefits:

• Health insurance
• Provident Fund

Work Location: In person