Principal Design Quality Assurance Engineer

Additional Location(s): Costa Rica-Heredia

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 this role: 
The Principal Design Quality Assurance Engineer is an experienced professional with wide-ranging experience and expertise in Sustaining quality engineering and New Product Development. The Principal Quality Engineer will develop, establish and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. 

This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills, MN or Heredia, Costa Rica.
 
Your responsibilities include: 

• Promote Cross-Functional collaboration and has ability to influence project strategy. Capable of working independently on highly specialized projects with long range objectives 
• Lead the execution of Quality Deliverables such as project Design & Development Plans, Design Changes, and Design & Usability Validation Plans. Leads the execution of Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety 
• Provide quality and compliance input and coaching for product development and/or post market product sustaining activities, such as design changes, product CE marking, customer complaint investigations, AI requests, NCEP’s and CAPA’s 
• Exercise considerable latitude in determining technical objectives of assignments. Selects methods and techniques to lead a project to completion with focus on translating organizational strategy into tactical deliverables
• Provide project direction, coaching, and mentoring for engineering and technical team personnel. 
• Develop solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques, and evaluation criteria for obtaining results
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues 
• Support internal and external regulatory audits 
• Provide technical leadership to business units. Advises management on potential improvements or enhancement to quality systems and processes 
• Support development, implementation and training of corporate quality initiatives
   

Required Qualifications:

• BS in Electrical Engineering, Mechanical Engineering or related degree 
• Minimum of 7 years of medical device engineering experience or similarly regulated industry
• In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management
• Solid technical writing skills
• Travel <10%, if required 

 
Preferred Qualifications:

• MS preferred 
• Strong communication and presentation skills

 

Requisition ID: 590564

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 commun