Junior Design Engineer

Job Title: Senior Design Engineer Reports to: D&D Head

Job Summary:

The Senior Design Engineer will lead the design and development of innovative medical devices, ensuring compliance with regulatory and industry standards. This role involves mentoring junior team members, managing complex design projects, coordinating with cross-functional departments, and preparing comprehensive design documentation for regulatory submissions. The candidate must have a strong understanding of manufacturing processes, regulatory expectations, and design control principles.

Key Responsibilities:

1. Design & Product Development

• Lead the design and development of new products and improvements to existing devices using SolidWorks and AutoCAD.
• Translate clinical and market requirements into functional designs while ensuring manufacturability and cost-effectiveness.
• Validate engineering calculations, tolerance stack-ups, and material selection for implantable devices and surgical instruments.

2. Project Leadership

• Plan and execute design activities in alignment with project timelines.
• Coordinate design reviews, risk analysis, and design verification/validation.
• Collaborate with the D&D Head to define design strategy and resource allocation.

3. Mentorship & Team Development

• Guide and mentor Junior Design Engineers in modeling, drafting, design analysis, and documentation.
• Review work submitted by junior staff and provide constructive feedback.

4. Manufacturing Integration

• Ensure designs are optimized for manufacturing processes such as CNC machining, laser marking, anodizing, and PEEK/titanium-specific considerations.
• Work closely with production, quality, and supply chain teams to ensure smooth handover from design to production.

5. Regulatory & Documentation

• Prepare and review Design History Files (DHF), Technical Files, Risk Management Reports, and Engineering Change Requests (ECRs).
• Ensure all designs and documentation meet CE MDR, US FDA, and CDSCO regulatory requirements.
• Support audits and regulatory submissions with accurate and complete documentation.

6. Design Evaluation & Predicate Comparison

• Conduct design benchmarking and engineering justification reports.
• Compare new designs against predicate or competitive devices for clinical and functional performance.

7. Innovation & Continuous Improvement

• Research new design trends, technologies, and surgical techniques in arthroscopy and orthopedics.
• Contribute to IP development, design patents, and publications where applicable.

Qualifications:

• Education:

Bachelors or Master’s degree in Mechanical, Biomedical, or Product Design Engineering.

• Experience:

3–6 years of experience in medical device design, preferably with exposure to orthopedic/arthroscopic implants and instruments.

• Skills:
• Advanced proficiency in SolidWorks and AutoCAD.
• Strong knowledge of GD&T, DFMA, FMEA, and design verification protocols.
• Familiarity with regulatory frameworks (CE MDR, US FDA 21 CFR 820, ISO 13485).
• Hands-on experience with prototype evaluation, testing fixtures, and validation tools.
• Good communication, leadership, and documentation skills.