R & D Engineer II - Sustaining
About The Position
Join our Vascular R&D Sustaining team, where we are dedicated to improving and sustaining commercial products that diagnose and treat peripheral vascular disease. Our mission is to enhance patient outcomes and improve lives through a broad and advanced portfolio of therapy solutions. We are seeking a dynamic and collaborative R&D Engineer III to support design improvements, supply continuity initiatives, and product lifecycle excellence. In this role, you will work cross-functionally to drive design and material changes, solve complex technical challenges, and ensure our commercial devices continue to meet the highest standards of quality and regulatory compliance. 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.
Requirements
- Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or a related technical field
- Minimum of 2 years' industry experience in an engineering role
- Proven ability to synthesize technical data from various sources and make sound recommendations
- Strong problem-solving skills and technical acumen
- Working knowledge of quality systems and regulatory standards, including ISO 13485 or 21 CFR 820
Nice To Haves
- Prior experience working in the medical device industry, preferably in a regulated R&D or sustaining engineering environment
- Experience with test method development
- Demonstrated success working within global or cross-functional teams
- Experience with design control, risk management, and DV/DVAL activities
- Familiarity with ultrasound technology
- Knowledge of peripheral vascular anatomy and related therapies
- Strong time management and project coordination skills
Responsibilities
- Support product design changes to maintain or improve supply continuity, including strategy development, feasibility studies, and testing activities
- Lead or assist in root cause investigations and develop robust engineering solutions to address technical and quality-related issues
- Ensure compliance with applicable regulatory standards, including ISO 13485 and 21 CFR 820, throughout the product lifecycle
- Collaborate with cross-functional teams, including project management, marketing, design assurance, manufacturing, and regulatory affairs, to ensure successful project execution.
- Prepare and review engineering documentation such as design change analyses, test protocols, technical reports, design history file components, and regulatory submissions.
- Present project updates and technical insights to stakeholders.
- Coordinate global engineering activities across Boston Scientific sites to align execution efforts and meet project milestones/
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
