Quality Design Assurance Engineer I

Work mode: 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

Partner with Design Quality (or Design Assurance (DA)), R&D Engineers and Technicians in the development and verification of an exciting novel Medical Device, which includes single use devices, capital equipment & software. Employee will work with a high-performing cross-functional New Product Development team to ensure safety, efficacy, quality and compliance of the system. This position will focus on development of a new product within the Interventional Heart Failure business through test method development, design verification, and risk management development.

Actively participate in all aspects of Design Control including systems and software. Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals, and priorities.

Your Responsibilities Include:

• Develop, update, and maintain Design History File and Design Input / Output documentation
• Update and maintain risk management files, such as Hazard Analysis, Task Analysis, and Design FMEA.
• Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
• Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Use problem-solving abilities to perform meaningful engineering work.
• Grow your skillset through a combination of training, hands-on experience, and mentorship.
• Interpret external standards and implement product requirements and testing to meet external standards
• Serve as a back-room representative during internal and external inspections and inquiries from regulators such as FDA and ISO as it relates to design assurance

Minimal Qualifications:

• Bachelor's degree in Biomedical Engineering
• 0 to 6 months of internship experience in design assurance, quality, in the medical device industry
• Experience with capital equipment product development in the medical device industry

Preferred Qualifications:

• Experience with design control, risk management, and medical device standards compliance
• Ability to communicate effectively with diverse cross-functional teams.
• Ability and passion to learn new technologies and find new solutions.
• Lab experience from classes or research.
• General familiarity with the design verification process
• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong written / verbal communication skills
• Knowledge of analytical techniques, problem solving and process improvement
• Knowledge of basic Quality System Requirements and Good Documentation Practices
• Prior internship experience with Boston Scientific