דרושים Sr Design Quality Engineer ב-Boston Scientific ב-United States, Minnetonka

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.

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 include:

• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance.
• Owns and drives commercial product monitoring and all related product sustainment activities.
• Key partner in all department goals and objectives.
• Act as an effective team member in supporting quality disciplines, decisions, and practices.
• Provides guidance and leadership to team of direct reports on workload management, priorities, and project execution.
• Continuously develops direct reports through individual development planning processes.
• Maintains and enhances cross-functional team relationships.
• Proactively investigates, identifies, and implements best-in-class quality practices.
• Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly.
• Assures activities and deliverables in area of responsibility meet regulatory and corporate requirements.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Directly interfaces with internal and external audit activities.
• Partners with internal and external stakeholders and vendors to ensure quality objectives are met and to provide solutions to quality issues.

What we're looking for in you:
Required Qualifications

• Minimum of a Bachelor's degree
• Minimum of 5 years of related work experience or an equivalent combination of education and work experience
• Minimum of 1 years of direct or indirect supervisory experience with a passion for leadership and team development
• Strong communication skills (verbal & written)
• Medical Device or regulated industry experience
• Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization
• Ability to travel up to 10% (Domestic and International)

Preferred qualifications

• Advanced degree in technical field or business
• Experience leading technical teams
• Experience with pharmaceutical or combination medical devices

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:

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.

Spencer Gregory Hale

About the role:

This position will start off at our Minnetonka, MN facility but will be transferred to our Maple Grove, MN by the end of 2025.

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.

Required qualifications:

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or related field
• 5+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
• Detailed 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:

• Demonstrated use of Quality tools/methodologies

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.