Key Responsibilities
Lead endtoend product development: concept, design, verification/validation, manufacturing transfer, launch, and sustaining
Own design control activities, including requirements, risk management, DHF, and V&V;
Translate user and clinical needs into explicit engineering solutions
Ensure designs meet performance, safety, manufacturability, and regulatory requirements
Partner with Quality, Regulatory, Clinical, Manufacturing, and Marketing teams
Support regulatory submissions (e.g., 510(k), technical files)
Manage external vendors and suppliers supporting development and testing
Support prototyping, testing, and design iteration
Provide technical leadership and mentorship to junior team members
CAD Tool : NX
Required Qualifications
Bachelor’s degree in engineering or science
5 to 10 years’ experience in medical device, biotech, or pharmaceutical product development
Proven experience leading products through the full design control lifecycle
Experience taking products from concept to commercialization
Solid communication skills and ability to work in a matrix organization
Experience with bioengineered collagen, ECM, or tissuebased prod
Roles and Responsibilities
Carries out engineering assignments of limited scope and complexity. Under the general direction of a senior engineer, is responsible for a project or part of a project or operation requiring a thorough knowledge of engineering and related fields (quality control, time and motion studies, etc.). Work is reviewed in detail with guidance given. May give limited technical guidance to junior professionals or technicians working on a common project. Typically has a Bachelor's Degree
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