R&D Engineer III -Sustaining

Additional Location(s): US-MA-Marlborough

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you advance your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

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 – Sustaining (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.

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 for this position at this time. Relocation assistance is not available for this position.

• 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.

• 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 information clearly to technical and non‑technical audiences.

• Experience working in the medical device industry, preferably in a regulated R&D or sustaining engineering environment.
• Experience supporting design changes, post‑launch product improvements, supply continuity, complaint reduction, or product lifecycle management initiatives.
• Experience with test method development, design verification, design validation, risk management, and design history file documentation.
• Demonstrated success working within global, cross‑functional teams that include quality, manufacturing, regulatory, clinical, marketing, operations, or supplier partners.
• Familiarity with Endoscopy devices, anatomy, therapies, or related clinical applications.
• Strong time management, project coordination, and communication skills with the ability to manage multiple priorities.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran status, or disability.