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Engineer, Sr Quality Job

Remote Eligible:  Hybrid
Onsite Locations(s): 

Marlborough, MA, US

Additional Locations:  Ireland-Cork

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Additional Locations: Ireland-Cork

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.


Senior Quality Engineer


About the role:
A Senior Design Assurance Quality Sustaining Engineer is responsible for assuring all requirements are met for the Product Lifecycle Process (PLCP), Risk Management, Design Controls and Usability Testing in support of sustaining and improving current products on the market. Works in fast paced Cross-Functional Teams to maintain and support 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.


Your responsibilities will include: 

  • Product Support: Lead collection and analysis of key quality trending information and data for Management Review and Complaint Reviews. Provide quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP’s, CAPA’s, PIR’s and Field Actions.


  • Champion Continuous Improvement: Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies). Lead the implementation activities for post-market surveillance, product feedback and corrective and preventive action programs. assurances, process controls, and CAPAs / systems designed to meet or exceed internal and external requirements.


  • Design Controls: Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, and Labeling) whether internal, co-developed or externally manufactured. Provide quality and regulatory guidance to assure country specific compliance to the laws and regulations of the targeted market for distribution. Champions 100% compliance to Company Policy and SOP’s. Support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements.


  • Audit Support: Support internal and external regulatory audits in a research capacity.


  • Quality System Champion: Advise management on potential improvements or enhancement to quality systems and processes in the company. Support development, implementation and training of corporate quality initiatives.  


What we’re looking for in you:
Minimum Requirements:

⦁    Bachelor’s Degree; preferably in Mechanical, Electrical, or Biomedical Engineering 
⦁    Minimum of 5 years of Medical device Engineering experience; with knowledge and experience in within Quality controls and standards
⦁    In depth familiarity with the FDA, ISO, MDD and the medical device industry quality requirements associated with product development, design controls, and product risk management.
⦁    Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, and EN 62366.
⦁    Strong communication and presentation skills.
⦁    Competent with use of Microsoft Office Suite


Preferred Requirements:
⦁    Masters Degree.  
⦁    7 + years of medical device engineering experience 
⦁    Experience within Minitab Statistical Analysis software (or equivalent) 


Requisition ID: 517294


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 is proud to be an equal opportunity and affirmative action employer.


Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


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.

Nearest Major Market: Boston

Job Segment: Quality Engineer, Medical, Electrical, Senior Quality Engineer, Engineering, Healthcare, Quality

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