Quality Eng - P3 jobs at Boston Scientific

About the Role:

In this dynamic production environment, they have the opportunities to develop, establish and maintain quality engineering methodologies, systems, and practices. Serving as representatives of the Quality organization, they will improve awareness, visibility and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.

Your Responsibilities Include:

• Partners with Manufacturing Engineering and Production core team members for daily manufacturing line support decisions and practices.
• Collaborates with cross-functional team to evaluate manufacturing results, assist defect detection, primary cause identification, and understanding corrective and preventative actions.
• Identifies and implements effective process control systems to support the development, qualification, validation and verification to meet or exceed internal, external, and regulatory requirements.
• Supports a culture of continuous improvement by advancing improvements to existing processes and controls.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Broadly engages with production teams across all shifts to develop and support solutions to improve outgoing quality.
• Provide task direction, coaching, and mentorship for technician team members.
• Participate in team decision-making and display team problem-solving/communication skills.

What We’re Looking For:Required Qualifications:

• Bachelor’s degree in engineering, technology, mathematics, or related science
• 2+ years of relevant experience in a regulated industry
• Strong verbal and written communications skills; Good documentation practices
• Works effectively in a Controlled Environment Area (CEA) manufacturing environment
• Self-starter with a proven ability to successfully work with minimal supervision
• Knowledge of basic Quality Management Systems
• Proficient with Microsoft Office tools (Word, Excel, PowerPoint, Outlook)

Preferred Qualifications:

• Medical device experience
• Comfortable with utilizing analytical equipment (including microscopes)
• Strong analytical skills, problem solving, and statistical analysis (Excel, Minitab)
• Experience with the following disciplines: manufacturing/process engineering, post-market complaints, supplier quality, CAPA, risk management
• Experience running/owning nonconforming event risk assessments and investigations
• Proficient using manufacturing control software (various MES, MasterControl, etc.)
• Project management experience

Maximum Salary: $ 132000

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.

Your responsibilities will include:

• Interpret and apply relevant cybersecurity standards and regulations (e.g., FDA/CMDE/MDCG Cybersecurity Guidance, IEC 62443, ISO 14971, HIPAA, GDPR) to ensure product compliance.
• Stay current with emerging regulations and standards related to medical device security (e.g., FDA Premarket Guidance, Post-market Cybersecurity Guidance).
• Collaborate with product development teams to embed security controls throughout the design, development, and maintenance phases.

• Self-motivated with a passion for solving problems and a bias for action.

• Ensure that medical device security engineering activities and deliverables (e.g., threat models, security risk assessments, security requirements, security test plans/protocols/reports, SBOM, post-market vulnerability management plans and reports, and cybersecurity labeling) comply with Boston Scientific's global quality system requirements and procedures.
• Collaborate with team on product security needs and requirements; review product security architectures and design specifications.
• Collaborate in planning of software verification and validation strategies.
• Review vulnerability assessments, fuzzing and penetration testing to identify and mitigate risks.
• Ensure continued consistent best practices and processes for secure coding, configuration management, and patching.
• Develop and implement risk mitigation strategies and maintain risk management documentation consistent across the ICTx portfolio.
• Oversee and enhance incident response plans and processes, ensuring rapid and effective resolution of security incidents.
• Drive continuous improvement of vulnerability management, including the evaluation and deployment of necessary patches or updates.
• Work closely with internal stakeholders (Software Development, R&D, Regulatory, IT, etc.) to align on security goals and requirements.
• Participate in internal and external audits, and address findings related to cybersecurity design and risk management processes.

What we’re looking for in you:

Required qualifications

• Bachelor’s degree in Cybersecurity, Computer Science, Computer Engineering, or a related field and 5+ years of experience in cybersecurity engineering, with a focus on product development and risk management or Master’s degree in Cybersecurity, Computer Science, Computer Engineering, or a related field and 3+ years of experience in cybersecurity engineering, with a focus on product development and risk management
• Proven experience leading security design and architecture reviews for complex, embedded medical devices or similar technologies.
• Demonstrated track record of creating and executing security risk assessments and mitigation strategies.
• In-depth understanding of cybersecurity frameworks (e.g., NIST Cybersecurity Framework).
• Understanding of privacy regulations (HIPAA, GDPR) and their intersection with medical device cybersecurity.
• Strong leadership, decision-making, and team-building capabilities.
• Excellent written and verbal communication skills for interfacing with technical teams, stakeholders, and executive leadership.
• Ability to work collaboratively across multidisciplinary teams, bridging gaps between technical, regulatory, and business functions.

Preferred qualifications

• 5+ years of experience working in the medical device industry or a similarly regulated environment; security architecture or medical device administration experience in healthcare settings is also a plus.
• Hands-on experience with secure coding practices, vulnerability scanning tools, fuzzing, and penetration testing methodologies.
• Knowledge of embedded systems security, wireless communications, network protocols, and PKI.
• Familiarity with FDA regulations and guidance documents for medical devices (e.g., 21 CFR Part 820).
• Working knowledge of SW96/TIR57/TIR97, IEC 62304 (software lifecycle), IEC 60601 (electrical safety), and ISO 14971 (risk management).
• Experience supporting VA Handbook 6500 compliance and ISO/IEC 27001 certification.
• Relevant certifications (e.g., GIAC, OffSec, CISSP, CISM, CRISC) are a plus.

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.

Applicants must be authorized to work in the United States without the need for employer sponsorship, now or in the future.

• Establishing category strategies that result in a sustainable competitive advantage.
• Managing strategic supplier relationships in line with company and category expectations
• Negotiating and executing contracts that deliver the best outcomes for Boston Scientific
• Driving sustained year-over-year value improvement related to quality, service, and cost.
• Defining technology roadmaps that align with long-term product and patient needs.
• Collaborating with Supplier Engineering to develop should-cost models.
• Gathering and analyzing market intelligence to report on trends, risks, etc.
• Identifying market and sourcing risks; work with stakeholders to define and execute mitigation plans.
• Providing key data analytics and reporting to support category and supplier strategies
• Supporting the broader sourcing team with data analytics and supplier communications
• Providing source selection recommendations for new products that align with the category strategy.
• Driving early supplier involvement with R&D to achieve development objectives, timelines, and reduce costs.
• Facilitating supplier business reviews; attend on-site supplier visits for assessments, negotiations, business reviews, etc.
• Facilitating the identification and evaluation of new materials and technologies
• Identifying and rationalizing insourcing vs. outsourcing opportunities
• Supporting or leading business process improvement projects
• Providing escalation support to site purchasing teams as required

• Bachelor’s degree in Supply Chain, Engineering, Business, or a related field
• Experience in Sourcing, Supply Chain Management, or Supplier Relationship Management
• Proficient with MS Office Excel and other applications (i.e., Word, PowerPoint, MS Project etc.)
• Ability to travel up to 20%.

• Minimum 2 years of experience in Sourcing, Supply Chain Management, or Supplier Relationship Management
• Master’s Degree or professional certification (i.e., CPSM, CPIM, CSCP, PMP, Lean Six Sigma, etc.)
• Experience sourcing for electronic components or medical devices.
• Experience working in medical device or similar regulated industry.
• Strong data analysis skills, with ability to translate data into strategy
• Ability to take direction and coaching from mentors
• Strong decision-making and negotiation skills, ability to influence internal and external teams.
• Ability to work independently and collaborate with cross-functional teams to complete projects.
• Strong interpersonal skills, with ability to communicate effectively with individuals on all levels.
• Strong critical thinking and analytical skills: process and results-oriented
• Detail oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively.

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.

Visa sponsorship:

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

Your responsibilities will include:

• Be a part of an extended project team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Supports departmental, functional, and divisional design quality goals and priorities.
• Executes methodologies to effectively meet individual and team objectives.
• Utilizes methodologies such as Statistical Analysis, Risk Management, and Root Cause Analysis in support of project activities.
• Ensures adherence to the quality system Policies, SOPs, and work instructions following Boston Scientific’s Product Life Cycle Process (PLCP).

Required qualifications:

• Bachelor of Science in Mechanical / Biomedical Engineering or related discipline in the sciences.
• Minimum of 2+ years experience in Design Quality Assurance, related experience in quality engineering or NPD design within a regulated industry
• Understanding of Quality tools and methodologies with an emphasis on Design Controls, Root Cause Analysis and Risk Management.
• Strong communication skills (verbal & written)
• Ability to work independently and as part of a team.
• Comfortable with complaint data reviews and interpretation
• Ability to travel up to 10%.

Preferred qualifications:

• Experience with pharmaceutical or combination medical device development
• Working knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820, 210, 211 (US QS Regulation), ISO 13485 (Quality Management Systems), EU MDR, and IEC 62366-1 (Usability).
• Experience with medical device development for single use device
• Experience with Electronic Medical Equipment.

Maximum Salary: $ 132000

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.

This is a defined term position with an expected duration of 1 year.

Your responsibilities will include:

• Identifying the opportunities for continuous improvement and initiates activities to support the improvement process.
• Leading quality projects of major magnitude and scope.
• Providing significant guidance and approval regarding technical strategies and approaches.
• Managing and providing direction to quality engineers on professional, personnel issues, and provides development opportunities.
• Providing guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high quality staff.
• Participating on team projects and assignments, facilitating or leading teams as necessary.
• Determining project staff assignments and schedules work to meet completion dates and deliverables.
• Working cross-functionally in identifying and resolving technical issues.
• Driving and evaluates project and department progress and results.
• Providing guidance and decisions on Operations and Design Control activities to ensure continued compliance with internal BSC procedures, and applicable regulatory and international standards as defined in the BSC Quality Policy and site Compliance Matrix.

Required qualifications:

• Bachelor degree
• Minimum of 7 years experience in medical device or similar regulated industry
• Minimumof 4 years leading cross functional teams in a technical field
• Able to travel 1-2 times a year

Preferred qualifications:

• More than 10 year of experience in Medical Devices or similar regulated industry
• Higher education MBA, MS in science or engineering
• Neuromodulation device experience, capital equipment experience
• Experience working with TUV, BSI, FDA etc
• Boston Scientific experience

Maximum Salary: $ 243000

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 2nd shift Quality Technician I (2pm-10pm) role will support MPC (Manufacturing, Packaging, and Chemistries) operations in Maple Grove. This role requires cross-functional collaboration with production, manufacturing, and quality team members. This role requires driving continuous improvement in product quality and compliance, owning and reporting nonconformances, and providing day-to-day quality support for manufacturing.

Your responsibilities will include:

• Downtime response to manufacturing floor issues
• Identify, solve, and scope quality issues on the manufacturing line including initiation, investigation, and completion of NCEPs.
• Provide technical, process, and quality support to product builders.
• Assist in quality training for product builders.
• Assist engineers in failure analysis and CAPA activities, including assignment as a CAPA project member.
• Revise existing documents, processes, and/or methods to correct or improve processes/products.
• Coordinate with upstream/downstream departments to adequately scope and contain nonconforming product.
• Identify and lead departmental initiatives related to best quality practices and continuous improvement.
• Identify, prioritize and resolve quality issues identified by metrics.
• Update databases and spreadsheets used to track, monitor, and report department activities.
• Use the inventory and traceability management systems to transact and research material.
• Assist with product failure analysis.
• Assist with audit-related activities.
• Participate in and follow direction with regard to basic statistical analysis and data collection.

Required qualifications:

• High school diploma/degree/equivalent work experience

Preferred qualifications:

• 1 year in the medical device field in a quality role
• Able to work independently under limited supervision as well as in a team environment
• Lean manufacturing experience
• Ability to proactively identify improvement opportunities

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

The ideal Principal Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative electrophysiology cardiovascular products portfolio. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.

Your responsibilities include:

• Lead Quality function for product development teams within the BSC Quality System to develop new Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES) as part of a core group of Design Quality Assurance (DQA) Engineers.
• Provide quality and compliance inputs to project teams for project decisions and deliverables (i.e. Design Change Analysis; Design Inputs, Design Outputs; Test Method Development and Validation; Design Reviews; Design Verification and Validation; Usability Testing; SW Validation; Process Validation; and Labeling).
• Provide quality and compliance inputs for post market product sustaining activities, such as design changes, Non-Conformance Reports (NCEP); Corrective and Preventive Actions (CAPA’s); Product Inquiry Report/Field Action Assessment (PIRs); Field Signals Evaluations and Field Actions.
• Lead Risk Management processes for new products with key inputs from cross-functional product development teams (i.e. Risk Management Plan, Risk Management Report, Risk/Benefit Analysis, Hazards Analysis, dFMEA, pFMEA, etc.)
• Engagement with project teams for Systems Engineering and Systems Risk Management as a Subject Matter Expert (SME).
• Lead NPD projects as a DQA SME and work with R&D Product Development Engineers to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
• Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Builds quality into all aspects of work by maintaining compliance to all quality requirements.
• Support internal and external regulatory audits as required.
• Other duties as necessary or required by the organization.

what we're looking for in you:

Required Qualifications

• B.Sc in Biomedical, Electrical Engineering or equivalent.
• 10 years of medical device engineering experience, with experience inMedical Electrical Equipment/Systems (MEE / MES).
• Applied knowledge in the verification and validation of Capital Equipment, including hardware, software, firmware, and systems of systems interdependencies.
• Experienced in working in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971, IEC 62304 and EN ISO 13485.
• Strong leadership, relationship building, and team building skills.
• Demonstrated ability to mentor and coach others in analysis and risk based decision-making processes to balance business and compliance needs.
• Strong communication and presentation skills.
• Strong applied knowledge of statistical concepts, tools, and methodologies.
• Travel approximately 5-10%.

Preferred Qualifications

• Experience with Software as a Medical Device (SaMD) and/or systems integration

Maximum Salary: $ 197000

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.