Senior Design Quality Assurance Engineer
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 Senior Design Quality Assurance Engineer is an experienced professional with wide-ranging experience and expertise in Sustaining quality engineering and New Product Development. The Senior Quality Engineer will develop, establish and maintain quality engineering methodologies, systems, and practices which meet Boston Scientific 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 based out of Arden Hills, MN with the expectation to be in the office a minimum of three days per week.
Your responsibilities include:
- Promotes Cross-Functional collaboration and has ability to influence project strategy. Capable of working independently on highly specialized projects with long range objectives.
- 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.
- Exercises 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.
- Provides project direction, coaching, and mentoring for engineering and technical team personnel.
- Develops 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.
- Supports internal and external regulatory audits.
- Provides 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.
What we’re looking for in you:
Required Qualifications
- BS in Electrical Engineering, Mechanical Engineering or related degree.
- 5 years of medical device engineering experience.
- Familiar with the FDA, ISO, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
- Strong communication and presentation skills.
- Solid technical writing skills.
- Travel
