Quality Design Assurance Engineer I

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:

Partner with Design Quality (or Design Assurance (DA)), R&D Engineers and Technicians in the development and verification of an exciting novel Medical Device, which includes single use devices, capital equipment & software. Employee will work with a high-performing cross-functional New Product Development team to ensure safety, efficacy, quality and compliance of the system. This position will focus on development of a new product within the Interventional Heart Failure business through test method development, design verification, and risk management development.  

Actively participate in all aspects of Design Control including systems and software. Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals, and priorities.

Your responsibilities include:

• Develop, update, and maintain Design History File and Design Input / Output documentation
• Update and maintain risk management files, such as Hazard Analysis, Task Analysis, and Design FMEA.
• Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
• Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Use problem-solving abilities to perform meaningful engineering work.
• Grow your skillset through a combination of training, hands-on experience, and mentorship.
• Interpret external standards and implement product requirements and testing to meet external standards
• Serve as a back-room representative during internal and external inspections and inquiries from regulators such as FDA and ISO as it relates to design assurance
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Minimal qualifications:

• Bachelor’s degree in Biomedical Engineering
• 0 to 6 months of internship experience in design assurance, quality, in the medical device industry
• Experience with capital equipment product development in the medical device industry

Preferred qualifications:

• Experience with design control, risk management, and medical device standards compliance
• Ability to communicate effectively with diverse cross-functional teams.
• Ability and passion to learn new technologies and find new solutions.
• Lab experience from classes or research.
• General familiarity with the design verification process
• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong written / verbal communication skills
• Knowledge of analytical techniques, problem solving and process improvement
• Knowledge of basic Quality System Requirements and Good Documentation Practices
• Prior internship experience with Boston Scientific

Requisition ID: 611276 

Minimum Salary: $ 58200 

Maximum Salary: $ 110500 

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.