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.
Our Team
Phillips Medisize is an expert in designing, developing and delivering 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.
What You Will Do
· Participate in the development of regulatory submission and approval strategy in multiple countries.
· Maintain awareness and understanding of new and existing regulatory requirements.
· Support identification of applicable regulatory requirements, their impact and how to interpret them.
· Execute regulatory strategy by applying regulatory requirements and generating documentation.
· Review and ensure compliance of the technical documentation.
· Assemble regulatory submission package and support submission process.
· Interact with customers and regulatory authorities to ensure regulatory approval/clearance.
· Maintain technical documentation to ensure continuous product conformity and approval.
· Contribute to alignment between development, risk, usability, clinical, testing & manufacturing team.
Who You Are (Basic Qualifications)
· Bachelor’s degree or better in life science or engineering.
· 5+ years of proven experience in quality or regulatory roles in the medical device industry.
· Deep understanding of the Medical Device Regulation (EU) 2017/745, and medical device development standards such as ISO 13485, and ISO 14971.
· Good understanding of technical and injector-specific standards, such as ISO 11608.
· Experience in preparing technical documentation intended to be used for submission in Europe, 510(k) submissions, Device Master File (MAF), and foreign registration.
· Excellent written and verbal communication skills in English.
What Will Put You Ahead
· High level of integrity, credibility, and empathy
· Global mindset 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 a technical level.
· Be able to handle multiple projects and home office tasks.
At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate’s knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.
Who We Are
- 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.
