Boston Scientific Principal R & Engineer - Sustaining 

United States, Minnesota, Minnetonka 

335916458

About this role:

Principal R&D Engineer, you will be a member of the Sustaining R&D team within Boston Scientific’s Urology Division. This division supports and sustains design and technologies for treating a wide range of urology-based issues, in addition to supporting evolving regulatory and standard requirements around product design.

In this role, you will lead cross-functional teams to develop/modify products, materials, processes, or equipment for projects of moderate and difficult complexity. Under limited supervision/guidance, you will compile, analyze, and report operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials. You will perform design change analysis to determine impact to products’ design history file and ensure deliverables needed to support design changes are executed by you or cross-functional team members to achieve project goals. Additionally, you will develop strategies to improve the overall technical expertise of the Urology Sustaining R&D group. A successful candidate will excel in a collaborative environment, possess strong technical skills in design elements and interactions, and demonstrate a proven ability to influence projects.

Your responsibilities will include:

• Successfully lead project teams typically including the following activities: innovative design development, complex design modification assessment, experiment design and execution, establishment of specifications and drawings, test of materials/products, research investigations, team report-outs, and cross-functional collaboration to drive all areas of project execution based on design controls knowledge and other impacted areas
• Provide design engineering for assigned Sustaining projects
• Serve as a R&D technical lead within a project
• Work independently to plan and schedule own activities necessary to communicate and meet timelines
• Design and coordinate engineering tests, experiments, and test equipment for R&D purposes and production support
• Lead troubleshooting and problem-solving on complex product/process issues related to design, materials or process
• Summarize, analyze and draw conclusions/recommendations from test results
• Prepare documentation and presentations to communicate complex results and topics to technical community
• Effectively communicate and present project status and technical details to all management levels
• Participate in budgeting and planning processes by providing input relating to Urology project portfolio
• Train, provide work direction, and/or mentor lab technicians or junior engineers
• Work cross-functionally with manager, project management, quality, process development, manufacturing, regulatory, clinical and marketing personnel to ensure project success
• Demonstrate strong design control knowledge and the Product Life Cycle through generation of high-quality deliverables

Required Qualifications:

• Bachelor’s Degree in Engineering – Biomedical or Mechanical engineering preferred
• 8+ years of work experience in engineering
• 5+ years of experience in medical device product development or sustaining projects
• Experience with design change assessment or impact analysis for regulated products
• Demonstrated ability to lead cross-functional teams/projects and influence outcomes without formal authority
• Experience or training in Problem Solving Processes
• Experience developing strategies or working on initiatives that result in long-term group improvements or benefits
• Strong 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 anatomical understanding of urological systems
• Strong statistical understanding and data analysis experience
• Self-starter with the ability to work independently and with a team to plan, schedule and execute activities necessary to meet project timelines to schedule and within budget
• Experience working with cross-cultural teams
• Experience with Class III medical devices
• Technical Project Management experience
• Experience with product lifecycle management systems (e.g. Windchill)

Maximum Salary: $ 188300

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.