Design Quality Assurance Engineer II - Endoscopy

Additional Location(s): US-MA-Marlborough; Ireland-Galway

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:

The Design Quality Assurance Engineer II directly supports medical device product development from concept through commercialization.  This individual will work with a high-performance cross-functional team to ensure the safety, quality, and compliance of our Endoscopy products. 

Provides quality engineering support as part of a new product development or sustaining team.  Develops, establishes, and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals, and priorities.

Work mode:

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Marlborough, MA and requires being on-site at least three days per week. We will also consider candidates based in our Galway, Ireland location.

Relocation assistance:

Relocation assistance may be available for this position at this time.

Visa sponsorship:

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

Your responsibilities include:

• Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, and Labeling).
• Creation and review of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA). Understand and support linkage of field data and Risk Management.
• Apply sound, systematic problem-solving methodologies to resolve quality issues.
• Champion compliance to company policies, work instructions and SOPs.
• Support Post Market activities such as assessment of risk based on post-market signals, field assessments
• Support effective quality assurance, process controls and metrics using data and statistical analysis to drive improvements.
• Lead the implementation of NCEP’s and CAPA’s while meeting or exceeding internal and external requirements
• Support internal and external regulatory audits as required.

What we’re looking for in you:

Required Qualifications:

• Minimum of a bachelor’s degree in engineering
• Minimum of three years of experience in design assurance, new product development, or related medical device experience
• Ability to travel up to 15% (international and domestic)
• Ability to be onsite for a minimum of 3 days per week

 
Preferred Qualifications:

• Master’s degree in engineering
• ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Demonstrated experience using Quality tools and methodologies
• Experienced in cross-functional collaboration and facilitating problem-solving
• Experience with design changes, complaint reduction, and corrective actions
• Strong communication (oral and written) and presentation skills.

Requisition ID: 628284 

Minimum Salary: $ 75100 

Maximum Salary: $ 142600 

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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

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 identity, 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.