Boston Scientific R & Engineer III - Sustaining 

United States, Minnesota 

745296719

About the role:

We are seeking a dynamic and collaborativeto 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.

Your responsibilities will include:

• 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/

Required qualifications:

• Bachelor’s degree or higher in Mechanical Engineering, Biomedical Engineering, or a related technical field
• Minimum of 3 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

Preferred qualifications:

• 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

Maximum Salary: $ 144400

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.