Medtronic is seeking a Senior Product Engineer to lead biological evaluations within a risk management framework, ensuring compliance with ISO 10993 standards and global medical device regulations. This role is crucial for supporting regulatory submissions and ensuring the safety of medical devices, particularly within the Diabetes business which is undergoing a separation to foster growth and innovation.
Requirements
- Strong understanding of ISO 10993 and global medical device regulations (e.g., EU MDR, FDA, REACH, Prop 65).
- Experience with biocompatibility assessments, toxicological risk evaluation, and material characterization.
- Experience with analytical techniques (e.g., LC, GC , MS) and drug compatibility testing.
- Knowledge of design control, risk management, and design verification/validation processes.
- Strong technical writing, data analysis, and statistical evaluation skills.
- Critical thinking skills to Interpret available data and recommend strategies to resolve technical challenges.
- Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
Responsibilities
- Lead biological evaluations within a risk management framework, ensuring compliance with ISO 10993 standards and global medical device regulations.
- Conduct comprehensive biocompatibility assessments, organizing and coordinating required testing, and authoring clear, concise, and well-structured biocompatibility evaluation plans and reports to support regulatory submissions.
- Apply scientific rigor in analyzing and characterizing materials, designs, and devices.
- Contribute to scientific efforts in a research and development environment, including the preparation of technical protocols and reports, as well as drug compatibility studies related to biocompatibility evaluations.
- Support product development by designing and executing design verification test methods and conducting statistical data analysis to assess product performance and functionality.
- Acquire working knowledge of ISO 10993 standards for biocompatibility. Maintains knowledge of the latest standards, regulations, and research in biocompatibility.
- Provide technical documentation concerning biological assessments of material and device safety per ISO 10993-1.
Other
- Requires a Bachelors degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
- Effective cross-functional collaboration and project management capabilities.
- Must be self-motivated and able to multi-task, meet tight deadlines and prioritize changing demands in a fast-paced environment.
- Energetic, enthusiastic, and enjoys the challenge of creative design.
- The ability to produce high-quality technical documentation and effectively communicate findings.
