We anticipate the application window for this opening will close on - 15 Sep 2025

 

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 Senior Product Engineer is responsible for leading biological evaluations within a risk management framework, ensuring compliance with ISO 10993 standards and global medical device regulations. This role involves conducting comprehensive biocompatibility assessments, organizing and coordinating required testing, and authoring clear, concise, and well-structured biocompatibility evaluation plans and reports to support regulatory submissions.

The Senior Product Engineer applies scientific rigor in analyzing and characterizing materials, designs, and devices, and demonstrates strong critical thinking, problem-solving, and decision-making skills. The role requires the ability to produce high-quality technical documentation and effectively communicate findings.

This position also involves close collaboration with multidisciplinary and cross-functional teams to ensure compliance with global chemical safety regulations (e.g., EU MDR, Prop 65, CLP, REACH), particularly in support of Materials of Concern assessments.

In addition, the Senior Product Engineer contributes 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.

The role also supports product development by designing and executing design verification test methods and conducting statistical data analysis to assess product performance and functionality. The candidate is expected to contribute to scientific presentations and author relevant technical publications as needed.

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

Responsibilities may include the following and other duties may be assigned.

• 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. Conduct biocompatibility impact assessment for changes on materials, processes, or intended uses of devices. Job includes coordinating and overseeing biocompatibility testing with external laboratories and analyzing test results to ensure compliance with regulations.

• Perform technical feasibility and design verification activities in a product development environment viz. biocompatibility, toxicological risk assessments, materials of concern (MOC), and insulin compatibility, either independently or in collaboration with department staff/contract test laboratories. Biocompatibility responsibility includes understanding chemical characterization data such that it integrates with biological evaluation report (BER).

• Liaise with internal (manufacturing, regulatory, quality, product development, supplier quality, post market surveillance, clinical) and external contacts (contract research organization (CRO), suppliers of raw materials and semi or finished products) to collect all the relevant information, and to ensure biocompatibility considerations are integrated into the product lifecycle.

• Where necessary, prepare devices for submission to internal and external test laboratories, maintaining good documentation practices. Document and maintain records of original information.

• Assist more senior members of the team in updating procedures, internal processes, data collection, report writing and standard gap assessments.

• Conducts exploratory research to produce new knowledge and potential products; conceives, organizes, promotes, and executes ideas and plans to new subcutaneous infusion devices.

Minimum Requirements: 

• Requires a Bachelors degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Nice to Haves: