Description Design Quality Assurance Engineer \xe2\x80\x93 Medical Device development Phillips-Medisize, a Molex company, is looking for an experienced quality engineer for Global Innovation Development in Bangalore, India. If you are interested in being part of a project organization and passionate about creating unique products for people who need medical treatment it might be you, we are looking for. 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. Main responsibilities

• Primarily responsible for: Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review, Review and approval of Clinical Evaluation Report.
• 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.
• Solutions-based approach to quality engineering, wants to provide \xe2\x80\x9cadded value\xe2\x80\x9d.

Education BE / ME/ Graduate/Postgraduate in Engineering/Science 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 8+ years\xe2\x80\x99 experience in new product development (NPD) focused on quality engineering related activities. Experience in the Quality Notifications, Customer complaints, Corrective & Preventive actions, Change management. Good understanding of Quality Management Systems. (ISO 13485, 21 CFR 820), cGMP. 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 Quality 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. Expert-level knowledge of current industry standards for New Product Development and risk management practices. Personal skills

• High level of integrity, credibility, and empathy
• Global mind set and ability to work in cross cultural contexts collaboratively with good communication.
• Self-motivated, results oriented & problem-solving skills.
• Open, honest, and accountable.
• Committed to deadlines and quality.
• Can-do-attitude and proactive mindset
• Proficient in English, written and verbal on technical level.
• Be able to handle multiple projects and home office tasks.
  

We offer you

• A great work culture which is highly human centric driven under the guidance of Principle based management which foster everyone to learn & grow to achieve career aspirations.
• A challenging position in an international innovative and successful company that is growing.
• An opportunity to setup the processes and development team in India to support the Indian customers.
• An opportunity to become part of a global team of dedicated and highly qualified colleagues based in Bangalore, India.
• Well-structured training and continuous development of your competencies.
• Exciting career possibilities within the constantly growing area of medical devices.
• Salary on a competitive level.

The Company \xe2\x80\x93 In Short

Phillips Medisize is an expert in the design, development and delivery of advanced drug delivery devices and connected health solutions. Our customers are leading pharmaceutical companies worldwide. We offer innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch. Phillips Medisize is a part of Molex. We have opened a new Global Innovation and Development center in Bangalore, India and expected to grow in the Asian region.