GRIPORTHO Medical Devices
Website:
griportho.com
Job details:
Senior Design Engineer
Company: Griportho Surgicals Private Limited
Location: Vadodara, India
Department: R&D / Design & Development
Reporting To: Head of Design Department / Technical Director
Job Summary
Griportho Surgicals Private Limited is seeking a highly skilled and motivated Senior Design Engineer to lead the design and development of orthopaedic implants, surgical instruments, and associated systems. The ideal candidate will be responsible for translating clinical and market requirements into manufacturable product designs while ensuring compliance with regulatory standards and internal quality systems.
The role requires strong expertise in mechanical design, medical device development, CAD modeling, and cross-functional collaboration with production, quality, and regulatory teams.
Key Responsibilities
Product Design & Development
- Design and develop orthopaedic implants, surgical instruments, and instrument sets in accordance with clinical and regulatory requirements.
- Conduct competitor analysis and worst-case scenario analysis to evaluate product performance, design limitations, and potential risks.
- Create detailed 3D models, assemblies, and manufacturing drawings using CAD software (e.g., SolidWorks, ESPRITCAM & AutoCAD) & 2D drawings for the same.
- Lead the concept development, prototyping, testing, and validation phases of product development.
- Ensure designs are optimized for manufacturability, durability, and cost efficiency.
- Rendering of CAD Models with proper material assignment along with Bone CAD Files.
- Perform DICOM file processing and segmentation (splicing) for the creation of accurate anatomical models to support implant and instrumentation design (optional skill).
Engineering Analysis & Validation
- Perform engineering calculations, tolerance analysis, and material selection for implant and instrument designs.
- Support mechanical testing, fatigue analysis, and validation studies for new products.
- Collaborate with the quality team to ensure compliance with ISO 13485, CE MDR, and other regulatory requirements.
Cross-Functional Collaboration
- Work closely with production, VMC/CNC programming, tool room, and quality teams to ensure smooth transition from design to manufacturing.
- Provide technical support during process development, tooling design, and production troubleshooting.
- Coordinate with marketing and clinical teams to incorporate surgeon feedback and market requirements into product improvements.
Documentation & Compliance
- Prepare and maintain design documentation, technical files, and engineering change records.
- Support regulatory submissions and maintain compliance with applicable medical device standards and documentation requirements.
- Maintain design control documentation as per quality management system (QMS) guidelines.
Continuous Improvement
- Identify opportunities for product innovation, cost optimization, and process improvements.
- Stay updated with advancements in orthopaedic technologies, materials, and manufacturing processes.
Required Qualifications
- Bachelor’s or Master’s Degree in Mechanical Engineering / Biomedical Engineering or related field.
- 3–6 years of experience in product design, preferably in orthopaedic implants, surgical instruments, or medical devices.
- Strong proficiency in 3D CAD software (SolidWorks preferred).
- Experience with precision manufacturing processes such as CNC machining, milling, turning, and surface finishing.
- Knowledge of orthopaedic implant design principles and materials such as Titanium and Stainless Steel.
Preferred Skills
- Experience with finite element analysis (FEA).
- Familiarity with ISO 13485, CE marking, MDR, and other medical device regulatory frameworks.
- Understanding of surgical procedures and implant biomechanics.
- Strong problem-solving, communication, and project management skills.
- Ability to conduct competitor analysis and worst-case scenario analysis.
- Proficient in CAD Modelling and 2D Drawing drafting.
- Splicing DICOM files. (optional)
Key Competencies
- Product design leadership
- Technical problem solving
- Cross-functional collaboration
- Attention to detail and precision
- Innovation and continuous improvement
Why Join Griportho Surgicals Private Limited?
Griportho Surgicals Private Limited is committed to delivering high-quality orthopaedic solutions through innovation, precision engineering, and strong clinical collaboration. Joining our team offers the opportunity to work on cutting-edge medical devices that directly contribute to improving patient outcomes worldwide.
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