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Senior Design Assurance Engineer -WATCHMAN Job

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.

Remote Eligible:  Hybrid
Onsite Location(s): 

Maple Grove, MN, US, 55311

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 Senior Design Assurance Engineer supporting WATCHMAN projects within the Interventional Cardiology division. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential, commercial experience, and perspective in the medical device industry.  The Senior DA Engineer will work with a high-performance cross-functional team to ensure safety, quality and compliance of WATCHMAN products to deliver the highest quality product to the customer.  
Your responsibilities include: 

  • Functional lead of work stream ensuring comprehensive assessment and implementation of DHF deliverables for PDPs.
  • Actively promote and participate in a cross-functional teamwork environment.
  • Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
  • Maintains product risk management documentation (i.e. Hazard Analysis, Fault Tree, FMEAs).
  • Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
  • Leads the development of and coordinate the execution and documentation of Design Validation and Verification activities.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
  • Perform regulatory standard assessments and support regulatory submissions to notified bodies.
  • Maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
  • Mentor 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:

Minimum requirements:

  • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or related field of study 
  • and 5 years experience in Design Assurance, new product development or related medical device experience; or Master’s degree and 3 years experience.
  • Self-motivated with a passion for solving problems and a bias for action
  • Ability to manage multiple priorities and work with ambiguity 
  • Hands-on approach to product development 
  • Strong communication skills (verbal & written)
  • Demonstrated use of Quality tools/methodologies.
  • ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
     

 

Requisition ID: 536778

 

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: Minneapolis

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