Principal Quality Engineer
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, process improvements and organizational quality goals. The position may mentor less experienced quality professionals and cross-functional stakeholders. Primary responsibilities include supporting 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. The role applies ISO 14971 risk management principles across product development, clinical investigations, design changes, commercialization and post-market activities. This is a hybrid position based at Boston Scientific's Maple Grove/Arbor Lakes location in Minnesota. Employees are expected to work on-site 3–4 days to support collaboration and business needs. Boston Scientific will not provide employment visa sponsorship or sponsorship transfer, and relocation assistance is unavailable.
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 engaging cross-functional partners such as 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 associated 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 identified product risks.
- Evaluate information from complaints, CAPAs, nonconformances, clinical investigations and post-market surveillance for potential impacts 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 methodologies to identify, prioritize, communicate and resolve quality issues.
- Drive development and execution of 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 associated with nonconformances and CAPAs for the hepatic artery infusion pump and accessories.
Benefits
- Core and optional employee benefits are offered; specific benefits are not listed.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
