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 :

Apply your skills and experience to ensure patient safety by joining the Design Assurance team at Boston Scientific. Thrive in a culture that prioritizes learning and development, builds lasting relationships with colleagues, and truly makes a difference to patients.

The Design Assurance Engineer I is a quality engineer that will support new product development and commercialized products within the structural heart valves division to improve the delivery of care for customers and patients around the world.

This role will work within high-performance, cross-functional teams by providing quality engineering support to design requirements, product verification and validation, risk management, design change control, and ongoing product design activities.

Your responsibilities will include :

• Apply sound, systematic problem-solving methodologies to resolve quality issues
• Actively promote and participate in a cross-functional teamwork environment
• Support the implementation and lifecycle management of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
• Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
• Generate protocols and reports to support verification and validation activities
• Establish and maintain Design History File and Design Input / Output documentation (Design Requirements, Component Specifications, and Prints)
• Monitor field performance of recently-launched and established medical devices against risk assessments

Required qualifications :

• Bachelor of Science degree in Engineering
• Strong communication skills (verbal & written)
• Comfortable working independently and as part of a cross-functional team
• Ability to manage multiple priorities and work with ambiguity

Preferred qualifications :

• Degree in Biomedical or Mechanical Engineering
• Knowledge of ISO 13485, ISO 14971, and Quality System Regulations
• Prior medical device industry experience
• Demonstrated use of Quality tools / methodologies
• Self-motivated with a passion for solving problems and a bias for action

Requisition ID : 583597

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 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 prohibited substance 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.