R&D Engineer II

Boston Scientific•Maple Grove, MN

11h•$71,500 - $135,800•Onsite

About The Position

Boston Scientific Interventional Oncology & Embolization (IO&E) is the market leader in therapies and technologies for interventional radiologists, offering Y-90 microspheres, ablation technologies, embolization products and a broad portfolio of ancillary solutions. We are seeking a motivated and collaborative R&D Engineer II to support the continued growth of the TheraSphere™ Y-90 franchise. In this role, you will contribute to global expansion initiatives, including market expansion efforts in China, while supporting sustaining engineering activities across the product lifecycle. You will work with a global, cross-functional team to advance innovative technologies that help improve outcomes for patients undergoing interventional oncology procedures. This position offers an exciting opportunity to influence product development, support international growth strategies and contribute to meaningful innovations that make a difference in patients' lives.

Requirements

Bachelor's degree or higher in mechanical engineering, biomedical engineering or a related engineering discipline.
Minimum of 2 years' experience with a bachelor's degree or minimum of 1 year' experience with a master's degree in an engineering environment.
Demonstrated ability to quickly learn complex technical concepts and solve challenging problems.
Strong technical aptitude, analytical thinking and problem-solving capabilities.
Effective written and verbal communication skills with the ability to collaborate across functions.
Proven ability to manage priorities, drive execution and deliver results against project timelines.

Nice To Haves

Experience within the medical device industry and a strong understanding of Design Controls.
Demonstrated success collaborating across functions and influencing stakeholders without direct authority.
Experience supporting global expansion, manufacturing transfer or localization projects.
Knowledge of interventional oncology procedures and associated clinical applications.
Experience with radiation-based therapies, combination products or pharmaceutical products.
Proficiency with CAD software, including SolidWorks, and statistical software, including Minitab.
Willingness to work with radioactive materials under controlled and regulated conditions.
Experience supporting acquired products or post-acquisition integration activities.
Prior exposure to CAPAs, remediation programs, audits or quality system improvement initiatives.
Ability to effectively operate at the intersection of engineering, quality and regulatory functions.

Responsibilities

Lead and contribute to cross-functional project teams supporting design changes, product enhancements and sustaining engineering initiatives.
Plan, prioritize and execute project activities independently to meet established timelines and deliverables.
Design, coordinate and execute engineering tests, test methods and experiments.
Design, procure and develop tooling, fixtures and test equipment as needed.
Investigate and troubleshoot product, process and manufacturing issues related to design, materials or processes.
Analyze test results, identify trends and develop data-driven conclusions and recommendations.
Prepare technical reports, protocols and documentation to communicate results and support project objectives.
Create, review and maintain engineering documentation in accordance with applicable quality system requirements.
Provide technical guidance and mentorship to technicians and junior engineers.
Collaborate with manufacturing, quality, regulatory, clinical, process development and marketing teams to ensure project success.
Support Design History File (DHF) maintenance and ensure documentation compliance throughout the product lifecycle.
Ensure compliance with FDA Quality System Regulation, ISO 13485, Boston Scientific Quality Management System requirements and applicable international regulations.
Apply Design Controls, Risk Management principles and Product Lifecycle Management processes throughout development and sustaining activities.
Generate innovative concepts for new products, technologies and process improvements and submit invention disclosures when appropriate.