דרושים Principal R & Engineer - Sustaining ב-Boston Scientific ב-United States, Minnetonka

Strategic Leadership & Commercial Execution

• Develop and execute strategic plans for the product portfolio, ensuring alignment across internal and external teams.
• Translate customer needs into actionable strategies that drive adoption, market share, and revenue growth.

Cross-functional Collaboration & Communication

• Serve as the internal product expert and key point of contact across the organization, providing strategic insight, market context, and portfolio guidance.
• Collaborate with Sales Operations, Integrated Communications, Field Sales, and other stakeholders to develop innovative marketing programs and sales tools.
• Partner with international colleagues to align global strategy with local market insights and opportunities.

Analytics, Market Insights & Product Expertise

• Serves as a clinical and functional expert to external and internal customers and the broader organization: the "go-to" person for guidance, insight and questions on capital and disposable product portfolio
• Conduct regular financial analyses to assess performance, identify trends, and refine commercial tactics.
• Gather and synthesize feedback from key opinion leaders, customers, market research, and internal stakeholders to inform portfolio decisions.
• Leverage core marketing competencies such as segmentation, positioning, messaging, and channel strategy to support top- and bottom-line growth.

Required Qualifications:

• Bachelor’s degree required.
• Minimum of 6 years of experience in strategic marketing, product management, or commercialization roles, preferably within healthcare or medtech.
• Demonstrated ability to develop and execute go-to-market strategies and value propositions.
• Strong influencing skills, with the ability to lead cross-functional teams without direct authority.
• Proven experience working with customers and internal partners to drive results.
• Strong analytical skills and financial modeling capabilities, with a strong understanding of market dynamics and competitive positioning.
• Willingness to travel domestically and internationally up to 30%.

Preferred Qualifications:

• MBA or other advanced degree preferred.
• Experience with medically oriented or clinically regulated products.
• Familiarity with new product development processes and commercialization within regulated industries.
• Global mindset and experience collaborating with international teams to adapt strategies for local markets.

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.

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.

About the role:

Senior R&D Engineer, you will be a member of the Sustaining R&D team within Boston Scientific’s Urology Division. This division supports design and sustain technologies for treating a wide range of urology-based issues including implants for treatment of urinary incontinence and erectile dysfunction, 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 team members to achieve project goals. 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: design development, design modification assessment, experiment design and execution, establishment of specifications and drawings, test of materials/products, research investigations, team report-outs, report preparation and test documentation, and cross-functional collaboration to drive all areas of project execution based on design controls knowledge and other impacted areas
• Provide design engineering support for assigned Sustaining projects
• Serve as a R&D 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
• Perform troubleshooting and problem-solving on complex product/process issues related to design, materials or process
• Summarize, analyze and draw conclusions from test results
• Prepare standard reports/documentation to communicate results to technical community
• Effectively communicate and present project status and technical details to management
• Responsible for engineering documentation
• 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
• 5+ years of work experience in engineering
• 2+ years of experience on 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
• 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
• Experience working with cross-cultural teams
• Experience with polymer-based medical devices (silicone-based preferred)
• Experience with product lifecycle management systems (e.g. Windchill)
• Technical Project Management 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

Maximum Salary: $ 156900

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.

Monday to Friday from 7AM – 3:30PM (Flexible)

About the role:

Responsible for supporting and assisting software/mechanical/ or electrical engineering activities. Often involves specialized equipment in a laboratory or bench environment.

Your responsibilities will include:

• Supports tools and /or software by creating and maintaining tools, involving others as appropriate to solve issues. Qualifies equipment, performs maintenance and calibration activities as required.
• Maintains detailed documentation through all phases of development, testing and analysis.
• Continuously improves process and work methodologies by interfacing with peers, engineers, and analyzing activities to improve workflow and work processes.
• Performs Design Verification and exploratory R&D testing. Documents test results and test reports by writing documents, reports, memos, change requests. Methods used are determined by approved procedures and standards.
• Works from schematics, engineering drawings, and written or verbal instructions.
• Supports NCEPs and CAPAs

Required qualifications:

• 3 years of experience with a high school diploma/degree/equivalent, or an equivalent combination of education/work experience

Preferred qualifications:

• Previous Medical Device experience
• Instron Blue Hill or Wave Matrix experience
• Mechanical aptitude
• Ability to work both independently and function as part of team.

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.

About this Role:

As a Principal Performance Improvement specialist you will support the Urology division, serving as a strategic resource to lead cross-functional performance Improvement projects, and drive the development of a sustainable, agile, high-performance culture. In this role, you will work with Urology divisional and functional leaders and stakeholders to drive improvement in key processes and systems and identify and support productivity opportunities across the Urology franchises.

Your Responsibilities will Include:

• Partner with leadership to develop performance improvement strategies, goals, and execution plans.
• Identify, develop and execute performance improvement programs and projects utilizing structured problem-solving methodologies. Perform or coach charter creation and scoping, root cause analysis, solution development and program plan roadmaps. Facilitate workshops for small and large teams.
• Champion / assist or lead change management efforts for programs and projects within your responsibility
• Contribute to, design and/or provide training on structured problem-solving methodologies.
• Assist with coaching performance improvement projects lead by others as needed across the division
• Collaborate with leaders and their organization/function to inspire a continuous improvement culture by deploying process improvement/operational excellence roadmaps, methods, and tools across the business.
• Influence key stakeholders to engage and participate in improvement activities essential to process and system improvement.
• Partner with leaders, champions, and employees to share best practices to further accelerate the rate of improvement.

What we’re looking for in you:

• Demonstrated history of successful performance improvement leadership and execution across multiple projects
• Passion for both the technical process of problem-solving and the people side of change
• Comfort in gray spaces and dealing with ambiguity
• Strong analytical acumen with the ability to make a significant contribution to performance improvement
• Self-starter and entrepreneurial/consultant mindset
• Ability to build enthusiasm for change
• Strong interpersonal communication and presentation skills

Requirements:

• 5+ years of Lean/Six Sigma/Continuous Improvement related experience
• BS/BA Degree in Engineering/Business or related field, Advanced degree preferred
• Certification in standard problem-solving methodologies
• Domestic and international travel of about 10%

Highly Preferred Requirements:

• Black Belt / Master Black Belt Certifications in Lean / Six Sigma and Project Management preferred
• Medical Device experience or experience in a highly regulated industry

Preferred Requirement:

• Experience in developing and/or delivering standardized problem-solving training
• Change management certification, or experience in applying change management principles
• Project Management / PMP certification

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.

About the role:

This position will start off at our Minnetonka, MN facility but will be transferred to our Maple Grove, MN facility in 2026.

Your responsibilities will include:

• Support the execution and documentation of Design Validation & Verification and Usability activities
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
• Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
• Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
• Lead and support cross-functional root-cause analysis investigation and resolution activities.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Support regulatory submissions to notified bodies.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedure.

What we're looking for in you:

Required qualifications:

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or related field
• 4+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
• Demonstrated use of tools/methodologies supporting Quality Engineering discipline including CAPA, risk management, design controls, problem solving, and data analysis.
• Understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, and EN ISO 14971.
• High energy problem solver capable of driving items to closure.
• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong communication skills (verbal & written)
  

Preferred qualifications:

• Experience with pharmaceutical or combination medical devices.

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.

Spencer Gregory Hale

The Sr Design Quality Assurance Engineer will develop establish and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. The Sr Design Assurance Engineer will serve as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. This Sr Design Assurance Engineer will provide focused quality engineering support within new product development, operational, or system/services support.

Your key responsibilities will include:

• Provides leadership role on championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Mentor for technical guidance for identifying and resolving quality issues.
• Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
• Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

Required Qualifications:

• Minimum of a bachelor's degree
• Minimum of 5 years of medical device engineering experience or other regulated industry with experience in Medical Electrical Equipment/Systems (MEE/MES)
• Understanding and practice of the FDA, ISO and the medical device industry quality requirements associated with product development, design controls, product risk management and usability engineering.
• Working knowledge of US and International regulations including any of the following: 21 CFR 820, is ideal, as well as the Medical Device Directive / Medical Device Regulation, EN ISO 13485, IEC 60601 and EN ISO 14971.
• Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent) and/or other electrical testing/simulation software
• Travel approximately 5-10%

Preferred Qualifications:

• Masters degree preferred
• Demonstrate ability to manage and complete multiple projects and objectives and lead cross-functional teams
• Strong track record of leading and influencing without direct authority across functional groups, leadership levels and regions.
• Experience in one or more of the following areas:
• Experience in Medical Electrical Equipment/Systems (MEE / MES).
• Experience with Software as a Medical Device (SaMD) and/or systems integration
• Strong communication and presentation skills

Maximum Salary: $ 156900

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.

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.