Principal R&D Engineer

Roche•Indianapolis, IN

1d•$112,000 - $208,000•Onsite

About The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Roche Diabetes Care is committed to helping people with diabetes live their lives. As a pioneer in the development of blood glucose monitoring and insulin delivery systems, we want our patients to be as active as possible and help healthcare professionals manage their patients' condition in an optimal way. The ACCU-CHEK® portfolio-from blood glucose monitoring through information management to insulin delivery - offers innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management. As a Senior Test Engineer, you will bridge the gap between scientific/clinical requirements and robust, life-changing hardware solutions. You will lead verification activities, tackle complex system-level challenges, and provide technical mentorship in a dynamic, cross-functional environment. You will provide high-level testing expertise to support product and lifecycle management. You will define and implement test strategies at the program level and across multiple scrum teams. You will lead submission and certification strategies for our CGM & BGM systems to ensure global market access. You will serve as the subject matter expert for Electromagnetic Compatibility (EMC) and Electromagnetic Voltage (EMV) testing, ensuring wearable devices meet all regulatory standards. You will define, mandate, and oversee complex work packages for external partners, including accredited laboratories, certification bodies, and national authorities. You will execute rigorous testing and evaluate results to assess product maturity. Ensure all verification content is "state-of-the-art" and compliant with international medical standards. You will act as a bridge between the user and the lab; translate customer usage data and market feedback into design improvements to enhance product reliability. You will modernize verification methods and automated test setups, supporting their continuous evolution to maintain a competitive technological edge. You will support product care and quality functions by leading detailed technical investigations into market complaints and field performance. This is an on-site position based in Indianapolis, IN. Relocation benefits are not being offered for this role.

Requirements

You have a Bachelor’s in Mechanical Engineering, Mechatronics, Electronics, or a related technical discipline with 7+ years of relevant experience, or Master of Science in Mechanical Engineering, Mechatronics, Electronics, or a related technical discipline with 5+ years of relevant experience
You have demonstrated experience in medical device verification, ideally within In-Vitro Diagnostics (IVD) or complex diagnostic instruments.
You have a high level of technical proficiency / "hands-on" expertise in hardware testing (e.g., PCBAs, sensors, battery life) and a strong conceptual understanding of embedded systems.
You have a solid understanding of regulatory knowledge, understanding the international standards for medical electrical equipment and the documentation required for regulatory submissions.
You are a proactive problem-solver who thrives on complexity, possesses a keen eye for detail, and can work independently within a collaborative framework.
You have demonstrated strong interpersonal and communication skills with the ability to communicate technical knowledge in a clear and understandable manner, especially to non-experts; you excel at problem-solving skills and the ability to work under ambiguous situations.
You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities; you complete work in a timely, accurate and thorough manner.

Nice To Haves

You have an advanced degree with 5+ years in the pharmaceutical/diagnostic space
You have demonstrated experience working in and outside of the lab; working closely with engineers and other stakeholders
You have experience supporting the development of a commercialized instrument/device.

Responsibilities

Lead verification activities, tackle complex system-level challenges, and provide technical mentorship in a dynamic, cross-functional environment.
Provide high-level testing expertise to support product and lifecycle management.
Define and implement test strategies at the program level and across multiple scrum teams.
Lead submission and certification strategies for our CGM & BGM systems to ensure global market access.
Serve as the subject matter expert for Electromagnetic Compatibility (EMC) and Electromagnetic Voltage (EMV) testing, ensuring wearable devices meet all regulatory standards.
Define, mandate, and oversee complex work packages for external partners, including accredited laboratories, certification bodies, and national authorities.
Execute rigorous testing and evaluate results to assess product maturity.
Ensure all verification content is "state-of-the-art" and compliant with international medical standards.
Act as a bridge between the user and the lab; translate customer usage data and market feedback into design improvements to enhance product reliability.
Modernize verification methods and automated test setups, supporting their continuous evolution to maintain a competitive technological edge.
Support product care and quality functions by leading detailed technical investigations into market complaints and field performance.