At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

The Scientist/Senior Scientist will provide an advanced technical expertise in biocompatibility assessment for Greater China R&D organization. He /she will manage the biological safety compliance process according to ISO, AAMI, GB, YY, and other country specific regulatory policies, guidelines, and procedures. He/she will assess material safety, conduct biocompatibility assessments, develop biocompatibility test strategy, select test methods, interpret results, solve technical issues, and address questions from regulatory agencies. He/she will conduct biocompatibility evaluation to support product development programs, regulatory submissions, process changes, and quality control procedures. He/she will serve as a liaison with Medtronic’s
biocompatibility/toxicology experts internally, and between standard organizations, industry peers, government laboratories, and research institutions to contribute on biological safety standard development externally.

• Be responsible for planning, initiating, and executing device biological safety evaluation through medical device during material scouting, product development, and regulatory submission process.
• Serve as a biological safety liaison between global product development teams. Provide guidance for testing related to new investigational and strategic device development programs during PDP. Provide professional advices and interpretations on regulatory requirements related to medical device submissions for all divisions.
• Develop plans, reports, conduct trouble shooting, and interpret test outcome of biological safety testing, bioanalytical and chemical characterization data to determine if device safety is sufficiently addressed.
• Ensure biological safety compliance of products developed at China R&D according to ISO 10993, GB/T 16886 standards, country specific policies, regulations, and guidelines (US FDA, EU, Japan, and China).
• Evaluate biocompatibility and toxicological contract research organizations globally, screen vendors to meet different business purposes. Conduct technical audits at CROs.
• Draft SOPs and other supportive documents as needed to provide directory and guidance on device safety assessment.
• Complete other assigned research tasks assigned by management.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.