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Product Development Engineer

2 months ago

Hyderabad, India Tek Support Full time
Position Overview:We are seeking a skilled

Product Development Engineer

with extensive experience in

medical device

development. This role involves leading the design and development of new medical devices, from concept through commercialization, while ensuring compliance with regulatory standards such as

FDA

and

ISO 13485 . The

Product Development Engineer

will work closely with cross-functional teams to ensure successful product launches and continuous improvement throughout the development lifecycle.

Key Responsibilities:Product Design & Development:

Lead the end-to-end design, prototyping, and development of medical devices, ensuring that designs meet performance, safety, and regulatory requirements.Concept to Commercialization:

Take medical devices from initial concept through development, testing, and commercialization, ensuring timely delivery of products to market.Design Verification & Validation:

Conduct design verification and validation (V&V) activities to ensure product functionality, reliability, and safety.Regulatory Compliance:

Ensure all product development activities comply with regulatory standards, including

FDA ,

ISO 13485 ,

GMP , and

CE Mark .Process Development:

Collaborate with manufacturing and quality teams to develop and optimize production processes for new devices.Prototyping & Testing:

Develop and test prototypes, using

CAD software

to refine designs and ensure product performance in clinical and real-world settings.Risk Management:

Implement risk management strategies, including

Failure Modes and Effects Analysis (FMEA) , to ensure product safety and compliance.Cross-Functional Collaboration:

Work closely with cross-functional teams, including R&D, Manufacturing, Quality Assurance, and Regulatory Affairs, to drive the success of product development projects.Documentation:

Maintain comprehensive documentation for all stages of product development, including design history files (DHF), risk assessments, and validation protocols.Continuous Improvement:

Drive continuous improvement initiatives to enhance product quality, reduce costs, and improve process efficiency.

Qualifications:Bachelor’s degree

in Mechanical Engineering, Biomedical Engineering, or a related field.4-6 years

of experience in

medical device product development , including experience in taking devices from concept through commercialization.Strong knowledge of

FDA regulations ,

ISO 13485 , and

GMP

for medical device development.Experience with

CAD software

(SolidWorks, AutoCAD) for product design and prototyping.Proficiency in design verification and validation (V&V) processes.Experience in

Failure Modes and Effects Analysis (FMEA)

and other risk management techniques.Knowledge of medical device manufacturing processes and production environments.

Skills:Expertise in

medical device development

and regulatory compliance.Proficiency in

CAD software

for product design and prototyping.Strong knowledge of

FDA ,

ISO 13485 , and other relevant medical device regulations.Experience with design verification and validation, risk management, and

FMEA .Excellent project management and communication skills.Ability to collaborate with cross-functional teams and lead product development projects.