Information Assurance jobs

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.

About the role:

As the Field Action Team Lead within Global Quality Systems at Boston Scientific, you will play a critical role in managing and executing the Field Action process including Product Recalls, Field Safety Corrective Actions, and Safety Alerts. This position leads cross-functional Field Action teams, coordinating execution across multiple business units while ensuring compliance with internal quality procedures and external regulatory requirements.

This highly visible role requires strong project management, communication, and collaboration skills to effectively guide stakeholders including Business Unit Leaders, Quality Business Process Leads, Regional Field Action Coordinators, and other team members. You will oversee multiple Field Actions at various stages of completion, minimizing risks and ensuring timely, compliant execution.

Your responsibilities will include:

● Lead all phases of project management for Field Actions—planning, execution, monitoring, and closure—to ensure team accountability and on-time delivery.

● Prepare and manage project schedules, budgets, and deliverables using tools such as Microsoft Project; define and track key project tasks.

● Assign responsibilities, monitor progress, assess risks, and implement contingency plans to maintain quality and project integrity.

● Communicate project status through regular updates and meetings; collaborate across departments to address and resolve issues.

● Lead postmortem evaluations to document lessons learned and identify future improvement opportunities.

● Develop and maintain project plans for product changes and field action development, reporting key progress to senior leadership.

● Coordinate, finalize, and ensure compliance of all Field Action communications with internal and regulatory requirements.

● Support continuous improvement initiatives within the Field Action process.

Required qualifications:

● Bachelor’s degree and a minimum of 4 years' experience in a regulated industry (e.g., medical device, pharmaceuticals, or biotechnology); or Master’s degree with a minimum of 3 years' relevant experience.

● Minimum of 4 years' experience managing cross-functional projects, including scope, schedule, and budget.

● Strong background in post-market, field action (recall), and quality system processes.

● Proficiency in Microsoft Office and project management tools (e.g., Teams, PowerPoint, Excel, MS Project, Visio).

● Ability to travel 0–10%.

Preferred qualifications:

● Bachelor’s degree in communications, technical writing, or a related field such as science, health, or engineering.

● Effective communication skills, including experience engaging regulators, clinicians, and cross-functional stakeholders.

● Strong writing, editing, and presentation capabilities.

● Demonstrated problem-solving skills and ability to synthesize complex technical inputs.

● Strong organizational skills, attention to detail, and multitasking abilities.

● High emotional intelligence, situational leadership, and ability to influence across teams.

● Proactive, results-oriented mindset with a focus on quality and continuous improvement.

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.

Your responsibilities will include:

• Develop and implement sales strategies by determining the relevant factors (e.g., product, competition, and pricing needs) of existing and potential accounts to effectively promote the company's products to appropriate hospital personnel and physicians.
• Develop action plans (i.e., weekly, quarterly, monthly) by analyzing quarterly and monthly sales figures and reports identifying the needs of particular accounts and discussing issues with Regional Sales Manager to help the organization achieve its annual sales goal.
• Determine the needs (e.g., product and pricing), goals, product usage, and types of cases handled by specific customers by meeting with and asking in-depth questions of physicians and other hospital personnel.
• Establish pricing packages to establish price points that address specific customer's needs while satisfying company guidelines and policies.
• Respond to customer needs and complaints regarding products and service by developing creative and feasible solutions or working with other related personnel (e.g. clinical research, pricing and/or marketing) to develop optimal solutions.
• Develop relationships with hospital personnel (e.g. through casual conversation, meetings, participation in conferences) to make new contacts in other departments within hospital and to identify key purchasing decision makers in order to facilitate future sales.
• Educate customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using a wide variety of formats and platforms (e.g., slides, transparencies, manuals) to secure purchasing commitments, often with the help of incentive programs and services made available to the account being developed.

Required qualifications:

• Minimum of a bachelor’s degree OR equivalent field clinical/sales experience.
• Minimum of 2 years medical device, pharmaceutical, or related sales experience.

Preferred qualifications:

• Experience selling cardiac monitoring equipment or cardiac related devices.
• Direct selling experience to physicians and hospitals.
• History and relationships with key players in the cardiac monitoring industry.
• Must have a technical aptitude; be able to discuss, explain software algorithms.
• Strong interpersonal skills, requires good communication skills, both verbal and written, and able to communicate effectively with diverse groups of people (physicians, office staff, etc.).

The anticipated annualized base amount for this full time position will be$, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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 testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

About the role:
This Senior Design Assurance Engineer will work on the Axonics Integration project, specifically supporting product Design Control integration under the direction of the Design Control Workstream lead. This position ensures that during the integration of products and Design Control quality system processes, the product and processes remain safe, of high quality, and compliant with BSC and regulatory requirements. This Design Quality role supports the active implantable design process for both existing and new products.

Your responsibilities will include:

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Acts as an effective team member in supporting quality disciplines, decisions, and practices
• Work within a cross-functional team to identify and implement effective controls and support integration of design control related products, records, and processes
• Write various technical documentation for procedure execution, technical rationale, and evidence of the development process.
• Support Design Assurance activities as related to Risk Management remediation, Design Control Quality System integration, and other DA related integration priorities
• Support Post Market activities, as necessary, of risk based on post-market signals
• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed
• Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
• Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)
• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Partner cross-functionally to identify and support value improvement efforts to support business goals

What we’re looking for in you:
Required qualifications:

• Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline)
• 5+ years of experience in design assurance, new product development or related medical device / regulated industry experience
• Self-motivated with a passion for solving problems and a bias for action
• Strong communication skills (verbal & written)
• Demonstrated use of Quality tools/methodologies
• Ability to effectively work and collaborate in a mixed onsite + remote environment
• Demonstrated experience creating detailed technical documents

Preferred qualifications:

• Experience working with medical electrical equipment and/or active implantables
• Quality Integration experience
• ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Experienced problem solver, capable of facilitating the problem-solving process
• Adaptable and effective collaborator in a team environment or in self-directed work
• Experience with design changes, complaint reduction, and corrective action

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.

Your responsibilities include:

• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance.
• Oversees the Design Controls and Risk Management aspects of Design History File, mitigate risks and ensure compliance with applicable regulatory standards during New Product Development.
• Translate strategy into action by converting broader organizational goals into specific objectives and tactical plans for the Quality Engineering team. Key focuses include New Product Development projects and goals, complaint reduction, value improvement and product performance challenges.
• Owns and drives commercial product monitoring and all related product sustainment activities including complaint signal management, CAPA and management of regulator responses.
• Communicate effectively. Interacts with and influences stakeholders at all levels of the organization, presenting complex challenges in clear and actionable manner.
• Act as a champion for quality disciplines, decisions, and practices. Lead in guiding team direction and execution of product and divisional programs. Promote accountability and a proactive mindset toward excellence.
• Provides guidance and leadership to team of direct reports on workload management, priorities, and project execution. Provides mentorship in quality technology, quality principles and overall regulation, risk management and design control concepts.
• Continuously develops direct reports through individual development planning processes.
• 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 including direct audit support locally and at several international manufacturing sites.
• Partners with internal and external stakeholders and vendors to ensure quality objectives are met and to provide solutions to quality issues.

Required Qualifications

• Minimum of a bachelor’s degree in engineering (Biomedical, Mechanical, Electrical, etc.) or equivalent fields of study
• Minimum of 8 years of related work experience in Design Quality or an equivalent combination of education and work experience
• Minimum of 3 years of direct or indirect supervisory experience with a passion for leadership and team development
• 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, risk management 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
• Strong strategic and critical thinking capabilities with the ability to balance long-term vision with executional excellence
• Excellent collaboration, communication, and interpersonal skills with the ability to work across cultures and geographies
• Ability to drive change in a matrixed, global organization
• Experience with problem solving including Six Sigma Certification(s)
• Strong communication skills (verbal & written) in a technical environment

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.

Your responsibilities will include:
● Support sterility assurance activities related to product development, manufacturing processes, and contamination control programs.

● Assist in sterilization modality selection and product validation strategy, including cycle design and documentation.

● Contribute to the implementation of best practices for contamination control and aseptic techniques across manufacturing and R&D environments.

● Collaborate with R&D, Quality, Regulatory, and Operations teams to ensure alignment with regulatory expectations and internal requirements.

● Participate in internal audits, regulatory inspections, and risk assessments to provide sterility assurance support and guidance.

● Apply knowledge of terminal sterilization methods (e.g., EO, gamma, moist heat) to solve technical challenges and support new product introductions.

● Engage with cross-functional project teams to ensure sterility assurance requirements are incorporated early in the development process.

Required qualifications:
● Bachelor’s degree in Microbiology, Pharmaceutical Sciences, Biomedical Engineering, or a related field (or equivalent experience).

● Minimum of 5 years' experience in sterility assurance, aseptic processing, or sterile product manufacturing.

● Working knowledge of terminal sterilization methods (e.g., EO, gamma, moist heat) and microbiological testing.

● Familiarity with global regulatory requirements related to sterility assurance (e.g., FDA, ISO, ICH).

● Strong collaboration and communication skills in cross-functional team environments.

Preferred qualifications:
● Master’s degree in a relevant scientific or engineering discipline.

● Experience supporting new product introduction in a regulated industry.

● Knowledge of contamination control practices in medical device or pharmaceutical manufacturing.

● Exposure to audits and regulatory inspections involving sterility assurance topics.

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.