Design Assurance Engineer II

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About the role:

We have an exciting opportunity for a Design Assurance Engineer II supporting new product development and sustaining activities specifically for the Opal system. This role focuses on ensuring the safety, quality, and compliance of both hardware and software components within the Opal platform. The position offers hands-on experience working with a cross-functional team in a fast-paced environment, providing excellent professional growth in the medical device industry.

The Design Assurance Engineer II will contribute to design controls, risk management, and software quality assurance activities to help deliver safe and effective products to customers.

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.

Requisition ID: 607836 

Minimum Salary: $ 72800 

Maximum Salary: $ 138300 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.