Principal Quality Engineer

Boston Scientific•Maple Grove, MN

8d•Hybrid

About The Position

The Principal Quality Engineer provides technical quality engineering expertise across product development, design changes, manufacturing operations and quality systems. The role establishes and maintains quality engineering methodologies, systems and practices that meet Boston Scientific, customer and regulatory requirements, and collaborates with quality management and cross-functional partners to advance quality initiatives and organizational goals. The position may mentor less experienced quality professionals and cross-functional stakeholders. The role supports quality systems, design change documentation and risk assessments associated with nonconformances and corrective and preventive actions (CAPAs) for Boston Scientific's hepatic artery infusion pump and accessories. It is a hybrid position based at the Maple Grove/Arbor Lakes location in Minnesota, with employees expected to work on-site 3–4 days to support collaboration and business needs. Visa sponsorship and relocation assistance are not available.

Requirements

Bachelor's degree in engineering, science, health sciences or a related field.
At least 5 years of experience in the medical device, pharmaceutical or a similarly regulated industry.
At least 5 years of experience working with quality systems and controlled processes.
Experience coordinating or managing CAPAs and quality investigations, including initiating and managing design changes.

Nice To Haves

Bachelor's degree or technical background in biomedical, mechanical or chemical engineering.
At least 8 years of experience in the medical device industry.
Experience leading CAPAs and quality investigations, including initiating and managing design changes.
Experience supporting quality systems, design change documentation and risk assessments associated with nonconformances and CAPAs.
Strong communication and collaboration skills, including the ability to engage contract manufacturers, suppliers, operations and supplier quality teams.
Ability to work independently, manage priorities and execute assignments with appropriate direction.
Previous experience with Boston Scientific's quality systems, processes or products.

Responsibilities

Apply advanced quality engineering principles to assigned products, processes and sites, guiding implementation to meet internal and external quality and regulatory requirements.
Champion departmental and cross-functional engineering initiatives, providing technical direction, coaching and mentoring to engineering and quality teams.
Identify, evaluate and implement quality engineering practices, processes and systems.
Develop and implement process and design control systems supporting product development, qualification and ongoing manufacturing.
Serve as a quality subject matter expert in applying ISO 14971 risk management principles across product development, clinical investigations, design changes, commercialization and post-market activities.
Lead or independently review risk management plans, hazard analyses, FMEAs, benefit-risk assessments, risk management reports and related documentation.
Ensure hazards, foreseeable sequences of events, hazardous situations, harms, risk controls and residual risks are appropriately identified and documented.
Assess implementation of risk control measures and verify their effectiveness in mitigating product risks.
Evaluate information from complaints, CAPAs, nonconformances, clinical investigations and post-market surveillance for potential effects on existing product risks.
Lead implementation and continuous improvement of quality assurance processes, process controls and CAPA systems.
Support cross-functional quality decisions and initiatives, using systematic problem-solving methods to identify, prioritize, communicate and resolve quality issues.
Drive efficient business processes and quality systems that enable timely identification and resolution of quality issues.
Partner with management to recommend and implement improvements to quality systems, processes and operational effectiveness.
Support quality systems, design change documentation and risk assessments related to nonconformances and CAPAs for the hepatic artery infusion pump and accessories.