Boston Scientific Principal Design Quality Assurance Engineer 

United States, Minnesota, Arden Hills 

661263802

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

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.

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.