R&D Engineer III - Sustaining

R&D Engineer III (P3)

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Boston Scientific's hybrid workplace includes Working From Home and onsite. You will have the opportunity to discuss details in the interview.

Join our Endoscopy Sustaining R&D team, where we protect product quality, compliance and business continuity across a portfolio of commercial medical devices. Our engineers improve and optimize released products, solve complex technical challenges, and ensure Endoscopy technologies continue to meet the needs of patients, physicians, and the business throughout their lifecycle.

We are seeking a dynamic and collaborative R&D Engineer III (P3) to support sustaining R&D initiatives, including product improvements, design changes, supply continuity projects, technical investigations, and lifecycle management activities. In this role, you will work in a cross-functional team to monitor product, material, process, and documentation changes; execute technical projects, and ensure commercial products continue to meet customer, patient, business, quality, and regulatory expectations.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Responsibilities:

• Support sustaining R&D activities for commercial Endoscopy products, including product improvements, design changes, test method development, design verification, and lifecycle management initiatives.
• Investigate technical, quality, supplier, or manufacturing issues; assess root cause; evaluate design or process alternatives; and recommend sound engineering solutions.
• Design, coordinate, and execute engineering tests and experiments; summarize, analyze, and draw conclusions from technical data to support decisions and recommendations.
• Assess the feasibility, robustness, and technical soundness of proposed product, material, process, tooling, fixture, or equipment changes.
• Prepare and review engineering documentation, including design change assessments, test protocols, technical reports, design history file deliverables, risk documentation, and regulatory submission inputs.
• Work closely with project management, quality, manufacturing, process development, regulatory affairs, clinical, marketing, and other cross-functional partners to ensure successful execution of sustaining engineering projects.
• Plan and schedule individual and small-team activities needed to meet project milestones and business objectives with limited supervision.
• Present project status, technical findings, risks, and recommendations to technical and cross-functional stakeholders.
• Demonstrate a strong commitment to patient safety and product quality by maintaining compliance with applicable quality system and regulatory requirements.

Minimum Requirements:

• Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or a related technical field.
• Minimum of 3 years of engineering experience in product development, sustaining engineering, or a related technical role.
• Experience analyzing technical data, drawing conclusions, and making recommendations based on inputs from multiple sources.
• Strong problem-solving skills, technical judgment, and ability to work through ambiguity with a hands-on approach.
• Working knowledge of quality systems, design controls, and regulatory standards, including ISO 13485 and/or 21 CFR 820.
• Ability to collaborate effectively across functions and communicate technical…