Senior Engineer – Design Quality Assurance

Main responsibilities

• Primarily responsible for: Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review, Review and approval of CER.
• Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
• Responsible to ensure provisions of Design Control processes are followed and associated reviews are conducted.
• Participate in design reviews during various phases of NPD.
• AQE should drive coordination with different departments (such a R&D, Regulatory, Clinical) to ensure the resulting part/product/process is safe, compliant, and effective.
• Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
• Expert-level knowledge of current industry standards for New Product Development and risk management practices.
• Solutions-based approach to quality engineering, wants to provide “added value”
• The Medical Device Design Assurance Engineer will focus on accelerating technical deliverables related to medical device design and development. The Medical Device Design Assurance Engineer will also support sustaining engineering activities and provide support to the Quality organization for quality initiatives. Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.

Education:-

• BE / ME in Engineering with more than 7 years of experience working with medical device design, FDA, ISO or other regulated environment and/or equivalent combination of education and experience.

Skills and Experiences:-

• 10+ years’ experience in new product development focused on quality engineering related activities.
• Good interpersonal and communication skills
• Good understanding of Quality Management Systems. (ISO 13485, 21 CFR 820)
• Experience on NPD process and various phases of new product development.
• Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards.
• Ensure that software, mechanical, electronic, and material/implant engineering follow the same approaches, wherever possible, to ensure seamless cooperation between these diverse disciplines and their associated system responsibilities.
• Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches.
• Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews and the other practices mentioned above.

Personal skills:-

• High level of integrity, credibility and empathy
• High level of personal engagement, energy and power to influence
• Excellent communication and collaboration skills
• Ability to focus on the most important topics to find good solutions
• Can-do-attitude and proactive mindset
• Self-motivated and results oriented
• Committed to deadlines and quality
• Open, honest and accountable
• Proficient in English, written and verbal on technical level
• Global mind set and ability to work in cross cultural contexts
• Be able to handle multiple projects and home office tasks

Location:-

• Bangalore, India.

Company Overview:-

Koch Engineered solutions (KES) is a global leader in emissions-control products, Mass transfer product and clean-air Combustion systems. We back every product with decades of proven performance, unrivalled research and development capabilities, and expert service and support. Our expertise includes: Burners, Flares, Flue gas treatment, Gas recovery, Landfill and biogas systems, Thermal oxidizers, Vapor control, Heat transfer, Mass Transfer, Oil, gas, and liquids separation, treating and conditioning, Combustion monitoring, Turnkey services, etc.