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Design Assurance Engineer III

2 months ago

Waltham, Massachusetts, United States Boston Scientific Full time
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 III supporting new product development and sustaining activities for the cardiac mapping and ablation systems within the EP division.

This position supports several product categories with high visibility which will provide the right candidate with excellent growth potential, commercial experience, and perspective in the medical device industry.

The DA Engineer will work with a high-performance cross-functional team to ensure safety, quality, and compliance of products to deliver the highest quality product to the customer.



Your responsibilities include:

  • Work cross functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success.
  • Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
  • Maintains product risk management documentation (i.
e. Hazard Analysis & FMEAs).

  • Leads/supports the development of and coordinates the execution and documentation of Design Validation and Verification activities.
  • Applies sound, systematic problem solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Supports and leads the execution and investigation of CAPAs, NCEP, Complaints, Failure Mode Investigations, etc.
  • Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
  • Able to navigate gray space by applying risk based criteria to prioritize project work.
  • Support cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables.

What we're looking for in you:

Required Qualifications:

  • Minimum of a bachelor's degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study.
  • Minimum 5 years of experience in Quality Assurance and/or Design Assurance, Sustaining, R&D, Manufacturing or related medical device experience.
  • ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.
  • Experience navigating design, manufacturing and/or supplier variations

Preferred Qualifications:

  • Strong understanding of NCEP/CAPA processes
  • Previous experience working to create/maintain risk documentation such as FMEAs and HAs
  • Experience working with Stature or FMEA MED 8 software would be excellent, but is not required
  • Self motivated with a passion for solving problems and a bias for action.
  • Ability to manage multiple priorities and work with ambiguity.
  • Strong communication skills (verbal & written).
  • Proficiency in collaborating with interdisciplinary teams.
  • Familiar with EP environment
Requisition ID: 584414

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.

This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.

The goal of the drug testing is to increase workplace safety in compliance with the applicable law.


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 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 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 prohibited substance free workplace. Pursuant to Va.

Code § , 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.