R&D Engineer III

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

Advancing possibilities for a brighter tomorrow

We are seeking an R&D Engineer III on a permanent basis to join our team.

Job Purpose:

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 to support sustaining R&D initiatives including product improvements design changes supply continuity projects technical investigations and lifecycle management 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.

Key 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.

Education & Experience:

• Honours bachelors degree (level 8) 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.

Preferred qualifications:

• 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.