Boston Scientific Design Assurance Engineer II 

United States, Massachusetts, Waltham 

177710278

Your responsibilities include:

• Collaborate cross-functionally with R&D, project management, manufacturing, regulatory, clinical, and marketing teams to support project deliverables.
• Support the implementation of Design Controls based on risk management, customer needs, and manufacturing inputs, focusing on both hardware and software aspects of the Opal system.
• Maintain and update product risk management documentation, including Hazard Analysis and FMEAs, ensuring coverage of software risks.
• Assist in the development, execution, and documentation of Design Verification and Validation activities, including software testing and static/dynamic analysis support.
• Apply problem-solving methodologies to identify, communicate, and support resolution of quality issues, including software defects and nonconformities.
• Support the investigation and documentation of CAPAs, NCEPs, complaints, and failure mode investigations related to the Opal system.
• Contribute to software quality assurance efforts by ensuring compliance with relevant standards such as IEC 62304 and ISO 13485.
• Assist with software validation and verification activities, including traceability and test documentation.
• Support risk-based prioritization and effective communication within the product lifecycle process.

What we’re looking for in you:

Required Qualifications:

• Bachelor’s degree in Materials, Mechanical, Electrical, Computer Science, Software Engineering, Biomedical Engineering, or related field.
• 2–4 years of experience in Quality Assurance, Design Assurance, Software Quality, Sustaining, R&D, or related medical device environment.
• Knowledge of Design Controls, Risk Management (ISO 14971), and Quality System Regulations (21 CFR 820) with emphasis on software and hardware.
• Familiarity with software quality standards such as IEC 62304, and validation concepts.
• Experience with risk management documentation such as FMEA, Hazard Analysis (software risk focus a plus).
• Ability to work effectively in cross-functional teams and manage multiple priorities.

Preferred Qualifications:

• Experience with CAPA and NCEP processes in a regulated environment.
• Hands-on experience or exposure to software quality assurance activities including static code analysis, software testing, or traceability tools.
• Experience working with software risk analysis tools or software testing frameworks.
• Strong analytical and problem-solving skills with attention to detail.
• Effective verbal and written communication skills.
• Self-motivated with a bias for action and continuous improvement.
• Familiarity with the Opal system or similar medical device platforms is a plus.

Maximum Salary: $ 138300

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.