Design Quality Engineer II

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 : The Design Assurance Engineer II is a quality engineer that directly supports medical device product development through the product life cycle from concept through commercialization.

This individual will work with a high performance cross-functional team to ensure safety, quality and compliance of the launched products while continuously improving their commercial value.

This position will focus on products for the Interventional Oncology and Vascular franchises. This position is based in Maple Grove, MN.

Your responsibilities will include :

• Apply sound, systematic problem-solving methodologies to resolve quality issues
• Act as an effective team member in supporting quality disciplines, decisions, and practices
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization
• Monitor field performance of recently launched and established medical devices against risk assessments
• Support Post Market activities such as assessment of risk based on post market signals, field assessments
• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed
• Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
• Generate, update, and maintain product risk management and Usability tools (e.g., Hazard Analysis, Fault Tree, FMEAs, Task Analysis)
• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input
• Partner cross-functionally to identify and support value improvement efforts to support business goals

Required Qualifications :

• Bachelor’s degree in an engineering related discipline
• Minimum of 2 years of experience in design assurance, new product development or related experience in a highly regulated industry
• Demonstrated use of Quality tools / methodologies
• Ability to travel up to 20% (Domestic and International)

Preferred qualifications :

• Medical Device industry experience
• ISO 13485, ISO 14971 and FDA Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Self-motivated with a passion for solving problems and a bias for action
• Strong communication skills (verbal & written)
• Experience with design changes, complaint reduction, and corrective action
• Adaptable and effective contributor in a collaborative team environment or in self-directed work

Requisition ID : 593124

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 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’s status, age, mental or physical disability, genetic information or any other protected class.

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.