Boston Scientific Senior R&D Engineer 

United States, Minnesota, Maple Grove 

540943063

R&D Senior Engineer, Peripheral Interventions Sustaining Engineering

Within the Peripheral Interventions (PI) Division we design, develop, produce and sustain technologies for treating peripheral venous and arterial disorders, in addition to supporting evolving regulatory and standard requirements around product design. We are able to provide a number of solutions to patients that include: Drug-Eluting & Bare-Metal Stents, Catheters, Balloons & Drug-Eluting Balloons, Microspheres, Thrombectomy and Atherectomy. PI has a robust product line and pipeline, and we will continue to make an investment in Interventional treatments.

Purpose Statement

This role is for an innovative technical contributor who shall sustain technology, products, materials, processes or equipment of moderate complexity for BSC’s PI Division. As a member of a team, you will develop, direct and execute plans for a segment of complex projects. Under limited supervision/guidance, you will compile, analyze and report operational, test and research data to establish/verify performance standards for products, processes and materials.

Key Responsibilities

• Successfully contributes to project teams typically including the following activities: sustaining engineering, design change strategy, test of materials, preparation of specifications, process capability studies, research investigations, report preparation and test documentation.
• Leads design change to ensure the proposed changes are systematically and thoroughly analyzed to verify that the design intent is still met.
• Maintain product performance through support of Quality Investigations
• Works independently to plan and schedule own activities necessary to meet timelines
• Designs and coordinates standard engineering tests and experiments
• Designs, procures and fabricates tooling and fixtures
• Performs troubleshooting on products/process problems as related to design, material or process
• Summarizes, analyzes and draws conclusions from test results
• Prepares standard reports/documentation to communicate results to technical community
• Responsible for engineering documentation
• Invents/creates concepts and designs for new products/processes, and submits idea disclosures
• May train and/or provide work direction to technicians
• Works cross-functionally with project management, quality, manufacturing, regulatory, clinical and marketing to ensure project success
• Support integration of newly acquired technologies into Boston Scientific
• Demonstrates design control knowledge through generation of high quality deliverables

Required Qualifications:

• BS (or more) in Biomedical Engineering or Mechanical Engineering from an accredited institution
• 5+ years related engineering experience in the medical device industry
• Proven ability to work within a regulated industry environment and with a track record of accomplishments. Product development experience a plus.
• A driven individual with the ability to work with a cross-functional group or independently to plan, schedule and execute activities necessary to meet project timelines to schedule
• Fundamental understanding of design controls and risk management within the medical device industry
• Fundamental understanding of the Quality System per ISO 13485 or 21 CFR 820

Preferred Qualifications:

• Biomedical or anatomy experience and/or aptitude
• Medical device product development system knowledge (PDP/TDP)
• Effective communication skills required due to support of cross functional projects within a team
• Experience working with cross-cultural teams
• Technical Project Management experience
• Systems engineering and electromechanical equipment sustaining / development experience a plus

Quality System Requirements

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.