Boston Scientific Principal Quality Assurance Engineer 

United States, Minnesota, Arden Hills 

58447485

At Boston Scientific, the Principal Quality Assurance Engineer is a professional with wide-ranging experience and expertise in Sustaining quality engineering. This person 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. Provides focused quality engineering support within new product development, operational, or system/services support.This is an onsite position based in Arden Hills, MN.

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.
• Influence and collaborates with the Product Development & Engineering team to ensure proper execution of Quality Deliverables such as project Design & Development Plans, Design Changes, and Validation Plans.
• Provide quality and manufacturing input and coaching for product and process development and product sustaining activities, such as reduction and control of Manufacturing process defects (scrap, nonconforming material, customer complaints)

• May be responsible for identifying issues requiring data queries & bounding to implement complex product stops & develop release criteria.

• Develops and implements product quality plans, documents, and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members. May be responsible for creating risk analyses and FMEAs.
• Provides project direction, coaching, and mentoring for quality engineering and technical team personnel supporting the product line(s).
• 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 unit. Advises management on potential improvements or enhancement to quality systems and processes.• BS in Biomedical, Mechanical Engineering or related degree.
• Minimum of 8 years of medical device engineering experience.
• In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements and New Product development
• Strong communication and presentation skills.
• Solid technical writing skills.
• Travel <10%, if required
Preferred Qualifications:• 10+ years of medical device engineering experience preferred.
• Experience supporting Finish Devices and Electrophysiology Division products.
• Experience in Product Line Acquisition & Transfers.

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.