Principal R&D Engineer

About the role:

Boston Scientific's R&D Team is expanding and currently seeking a Principal Engineer to join our Electrophysiology team within the Cardiology division. This is an exciting opportunity to contribute to one of Boston Scientific's fastest-growing areas.

As a Principal Engineer, you will be part of a high-performance team dedicated to support the commercial phase of disposable medical devices in the electrophysiology space. This role is integral to best-in-class development practices and rigorous, holistic product design—collaborating closely with internal and external partners to bring innovative solutions to patients.

The "Principal" role represents a highly experienced professional who leads complex projects within the department. This position is an individual contributor role, meaning it does not include direct people management responsibilities, yet operates at a level equivalent to management in terms of scope and influence.

Your responsibilities include:

• As an individual researcher, drives complex or novel assignments requiring the development of new or improved techniques and procedures. Work is expected to result in the development of new or refined technologies, products, materials, processes, equipment, and or scientific methods.
• Uses knowledge and skills and is regarded as a knowledgeable and experienced resource who can quickly generate unique and creative solutions to technical challenges that the team cannot otherwise resolve.
• Assesses the feasibility and soundness of alternative engineering processes, products, or equipment when necessary data are insufficient or confirmation by testing is not advisable.
• Researching, designing, and evaluating mechanical and electro-mechanical materials, components, assemblies, and processes.
• Leading complex single-use device sustaining efforts including requirements, design, prototyping, testing, manufacturing transfer, V&V.
• Developing solutions to challenging engineering problems requiring ingenuity and collaboration across functions.
• Analyzing system-level issues and driving technical decision-making in cross-functional teams.
• Ensuring compliance with the Design Control deliverables throughout all the phases of the product life cycle.
• Esuring compliance with country specific regulatory requirements, such as FDA, EU MDR, among other.
• Integrating product-level documentation with broader system requirements.
• Organizing and planning project assignments with a focus on technical excellence and timely delivery
• Driving continuous improvement in product development and ensuring compliance with quality systems.
• Providing mentorship, technical guidance, and fostering a high-performance team culture.
• Drafting and submitting intellectual property.
• Maintaining detailed documentation throughout all research and development phases.
• Communicating effectively with internal stakeholders and external partners.
• Building strong cross-functional relationships to advance program goals.

What we are looking for:

• Bachelor's/Licenciature Degree: Mechatronics, Electronics, Electrical, Mechanical, Materials Science, or related field.
• English level: +90%.
• Experience: Minimum of 7 years' experience in the medical device industry with a BS/Licenciature, Master/PhD degree is a plus.
• Knowledge of ISO 13485, EU MDR, and FDA medical device requirements, including design controls, product life cycle, validation/verification activities, and process improvement.
• Experience with Design Controls and Product Development Process in medical devices
• Proven experience managing technical aspects of cross-functional project teams
• Demonstrated ability to collaborate across functions and influence without authority
• Strong passion for understanding and solving problems for end users
• Excellent verbal and written communication skills
• Ability to travel internationally.