Lead Design Engineer

Job Description Summary
The lead design and development engineer will be responsible for multi domain activity collaborating with different layers of the company to ensure the best product output. The role of R&D engineer is very crucial as the company aims at developing innovative products in the healthcare domain. The role is surprisingly challenging as it not only deals with real world engineering problems as well as problems of the healthcare sector which evolve day by day,

Job Description
Essential Responsibilities

• Ability to apprehend the market needs and convert them into product idea.
• Keeping regulatory and compliance always a priority while setting design parameters.
• Constant interaction with the Industrial designer.
• Producing the drawing files for the manufacturing.
• Research paper drafting and publishing along with clinical specialist and other team working on the product.
• Providing models and sketches to patent attorney for patent filing.

Required Qualifications (Must have):

• Bachelor’s degree in Engineering (mechanical or polymer)/Pharmacy/ Science with 10+ years of experience design & development engineering or manufacturing engineering, etc. in relevant industry such as medical device industry, automotive industry, aerospace industry or general engineering industry.
• Basic design and development cycle knowledge.
• Basic understanding of the manufacturing processes for a time-to-time supplier development activity.
• Proficient in any of the CAD software (CATIA, SOLIDWORKS ETC.)
• Basic knowledge of rapid prototyping and 3D printing.
• Knowledge of Finite Element Analysis.
• Expert knowledge of plastic and silicon moulding processes.
• Basic understanding of human biology and bodily functions such as reproduction.
• Professional level understanding of project management and planning.
• Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details
• Strong project management and prioritization skills, ability to effectively manage multiple tasks and priorities
• Superior ability to lead change with global, cross-functional teams & proven ability to drive operational excellence

Good to have:

• Expert knowledge of Good Manufacturing Practices & Regulatory requirements, ISO 13485, ISO 14971, India Medical Devices Rules, US FDA 21 CFR 820, EU MDR
• Understanding of material behaviour upon interacting with human body and their various uses & their properties. (like silicone, medical grade plastic etc.)

Desired Characteristics

Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.