Design Quality Assurance Engineer I - Electrical

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:

At Boston Scientific, we value collaboration and synergy.

This role follows a hybrid work model requiring employees to be in our local office three days per week.

This position may be eligible for relocation assistance.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

This Design Quality Assurance Engineer I - Electrical role will lead the effort to establish and maintain MEE/MES in partnership with a diverse and high-performing team. This role will require engineers to provide technical support for the integration of Single Use Devices (SUD) with MEE to form systems that will provide imaging solutions to facilitate further examination and/or delivery of therapy to the bile or pancreatic duct.

An engineer in this role will employ creative and resourceful problem-solving skills while working with moderate to complex mechanical and electrical devices. Methodologies in identification, prioritization, and communication are employed to aid in resolving quality issues. This position will utilize best practices in engineering to lead efforts for requirements development/management of system architecture to align risk mitigations with design inputs and design outputs at various levels (e.g., system/sub-system) for products that are both stand-alone and/or network connected.

Your responsibilities will include:

• Provide insight to identify risks through all phases of Electrical Hardware design using quality assurance principles applicable to FDA/EUMDR-Regulated Class II Medical Device environments including the remediation of legacy commercialized products

• Create and maintain risk management and usability documentation such as the Hazard Analysis, Design Failure Modes and Effects Analysis (DFMEA), Task Analysis, and Fault Tree Analysis (FTA) while incorporating IEC 60601-1, IEC 60601-1-2 and/or IEC 62304 and Cybersecurity principles

• Manage MEE/MES suppliers to ensure Boston Scientific improves the quality of patient care and all things Boston Scientific

• Post-market surveillance for commercialized devices conducted through the support of trending and product performance, including the identification of signals and nonconformities

• Ownership of Nonconforming Events and Prevention (NCEP) and Corrective Action/Preventative Actions (CAPA); the use of analytics will be required to ensure patient care and product performance are not compromised

Required qualifications:

• Bachelor of Science in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or another engineering degree with a minor in Electrical Engineering or equivalent electrical experience.

• Proficient with Microsoft Office tools, including Word, Excel, PowerPoint, and Outlook.

• Hybrid position located in Marlborough, MA, USA; must be able to perform work duties onsite at least 3 days per week.

Preferred qualifications:

• Master's degree preferred.

• Familiarity with IEC 60601-1, IEC 60601-1-2 and/or IEC 62304.

• Minitab Statistical Analysis software (or equivalent) .

• Focus on detailed work with emphasis on accuracy and completeness.

• Excellent organizational and planning skills; drives for results.

• High energy problem solver capable of driving items to closure.

• Ability to collaborate and work on a global team.

Requisition ID: 613553

Minimum Salary: $ 61000

Maximum Salary: $ 115900

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see --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.