Head Design & Development

Brief About the Role:

The Head- Design & Development will manage a team of 15+ highly experience Design Engineers and work on product development of variety of Accessories, Instruments and Implants. The successful candidate must excel in a fast-paced team environment, and be capable of creative problem solving, when faced with the time pressures and design constraints typical of product development. He or she must have a strong sense of ownership, shared responsibility, commitment to high product quality and be comfortable in collaborating across organizational boundaries. Projects will include a mix of new product development, product improvements, cost savings and manufacturing improvements to enable significant volume growth.

Roles and Responsibilities:

1. Design, develop and document components and assemblies for surgical system accessories:

 Create product functional and design specifications.

 Create, analyze, and test product designs and their components.

 Research, understand and design to relevant product specific standards.

 Develop, implement, test, and document solutions that meet clinical, functional and product requirements.

 Conversant and apply Design for Manufacturing (DFM) and Design for Manufacturing and Assembly(DFMA) concepts.

 Optimize the application of GD&T to a feasible DFM, without compromising the engineering requirements to obtain a safe and effective device.

 Identification and right selection of materials, suitable for sterilization processes and bio-compatibility.

 Support and participate in clinical and human-factor evaluations for new designs or design changes to ensure positive user experiences.

2. Provide mechanical engineering expertise to support continuous production of high-quality surgical accessories to our customers:

 Collaborate with the cross functional team to facilitate effective transfer of designs into production.

 Work within multi-disciplinary teams to define requirements for new and current designs.

 Develop mechanical assemblies, with careful consideration for key functions and safety, while designing for manufacturing-ability, reliability, and cost.

 Develop components and product mechanical drawings in a regulated environment.

 Design the products using the knowledge of various bio-compatible plastics and their processing efficiency, either in injection molding or in machining, thermoset compression molding, etc.

 Conduct the Design Verification and Design Validation per ISO 13485.

 Develop Design History Files per FDA requirements.

 Contribute to the determination of future product release content.

3. Develop 2D and 3D drawings, and the outputs are preserved as hard and soft copies in a controlled manner, as per the QMS of the organization.

4. Provide technical advice and mentoring to other design engineers.

5. Help establish individual and team goals aligned with overall project and company goals.

Desired Education, Skills & Competencies:

 BE/BTech in Mechanical Engineering preferably with minimum 2 years certification from CIPET or GTTC or NTTF in Injection Mold Design.

 Minimum 15 years of medical products design & Development

 Hands-on experience in high precision Product Manufacturing & Design Industry will be

preferred.

 A passion for solving tough technical problems - strong mechanical intuition and persistence to drill down to pinpoint root cause of problems and solving problems using fundamental principles are desired qualities.

 Demonstrated ability to think at a systems level, interface between multiple design groups, and negotiate conflicting requirements.

 Proven experience with design for assembly, manufacturing, and automation.

 Demonstrated knowledge of materials (including all types of plastics, silicons, isoprene) and material properties.

 Ability to apply knowledge of engineering materials and component selection criteria to product designs through strong concept development, design analysis, hands-on prototyping, and reliability testing skills.

 Proficiency using CAD to design parts and assemblies and to create specification drawings in a PDM environment; Solidworks, AutoCAD and NX strongly preferred.

 Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer.

 Comfortable with concepts of design input, design output, traceability, and risk analysis.

 Ability to communicate effectively and accurately (written and oral) across all levels and functions, including presenting to a technical audience.

 Strong desire to mentor junior engineers and Designers.

Job Location: Kundli, Sonipat- Haryana.