Principal Design Quality Assurance Engineer

Boston Scientific Gruppe; Newton (MA); On-site; USD 103,000 - 197,000; Full time

Job summary

A leading company in the medical device industry is seeking a Principal Design Quality Assurance Engineer to lead quality assurance efforts within product development teams. This role focuses on medical electrical equipment and systems, requiring substantial experience in regulatory environments and strong leadership capabilities.

Qualifications

• 10 years of medical device engineering experience.
• Knowledge of FDA, ISO, and IEC standards.
• Familiar with verification and validation processes.

Responsibilities

• Lead the Quality function for production development teams.
• Support post-market activities and risk management processes.
• Ensure quality compliance across all work aspects.

Skills

Leadership

Relationship Skills

Team Building

Communication

Statistical Concepts

Education

B.Sc in Biomedical Engineering

Electrical Engineering

Job description

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Principal Design Quality Assurance Engineer

Onsite Location(s):

Waltham, MA, US, 02138

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we offer opportunities to work with diverse, high-performing teams on important health challenges. We provide access to the latest tools, training, and support to help you advance your career and achieve your ambitions.

About the role

The ideal Principal Design Quality Assurance Engineer will lead new product development and sustaining projects for our electrophysiology cardiovascular products. They will develop and maintain quality-engineering methodologies, systems, and practices meeting BSC, customer, and regulatory standards.

Your responsibilities include:

• Lead the Quality function for product development teams within the BSC Quality System, focusing on Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES).
• Provide quality and compliance inputs for project decisions and deliverables, including Design Change Analysis, Design Inputs, Design Outputs, Test Method Development and Validation, Design Reviews, Verification and Validation, Usability Testing, Software Validation, Process Validation, and Labeling.
• Support post-market activities such as design changes, Non-Conformance Reports, CAPAs, Product Inquiry Reports, and Field Actions.
• Lead Risk Management processes for new products, including Risk Management Plans, Reports, Risk/Benefit Analyses, and Hazards Analyses.
• Engage with project teams as a Subject Matter Expert in Systems Engineering and Risk Management.
• Review hardware/software architecture for new products, identifying failure modes and risk controls.
• Collaborate within teams to identify and implement controls supporting product compliance.
• Ensure quality compliance across all work aspects.
• Support internal and external regulatory audits.
• Perform other duties as required.

Required Qualifications

• B.Sc in Biomedical, Electrical Engineering, or equivalent.
• 10 years of medical device engineering experience, especially with MEE/MES.
• Knowledge of verification and validation of Capital Equipment, hardware, software, firmware, and systems of systems.
• Experience with regulated environments (FDA, ISO, EUMDR, IEC standards).
• Strong leadership, relationship, and team-building skills.
• Ability to mentor in analysis and risk-based decision-making.
• Excellent communication and presentation skills.
• Proficiency in statistical concepts, tools, and methodologies.
• Willingness to travel approximately 5-10%.

Preferred Qualifications

• Experience with Software as a Medical Device (SaMD) and systems integration.

Requisition ID: 607278

Salary Range: $103,700 - $197,000

The actual compensation will vary based on location, experience, education, and organizational needs. Boston Scientific is committed to diversity and inclusion and is an equal opportunity employer. We also comply with applicable COVID-19 vaccination requirements and substance testing policies for safety-sensitive positions.

Join us in advancing science for life, transforming lives through innovative medical solutions, and making a meaningful difference worldwide. We value diversity and inclusion, believing it enhances our innovation and reflects the communities we serve.