Senior Design QA Engineer - Electrophysiology

Boston Scientific Gruppe; Waltham, Northern (MA, KY); Hybrid; USD 107,000 - 203,000; Full time

Benefits offered by this job

Relocation assistance

Hybrid work arrangement

Job summary

Boston Scientific in Waltham, MA is seeking a Principal Design Quality Assurance Engineer for the Electrophysiology portfolio. You will lead quality activities across new product development and sustaining projects, building robust quality engineering methods to meet regulatory requirements.

The role emphasizes collaboration, risk management, design verification/validation, and support for internal and external audits.

Qualifications

• Bachelor’s of Science in Biomedical, Electrical Engineering or equivalent.
• 10 years of medical device engineering experience with MEE/MES.
• Experience in verification and validation of Capital Equipment (hardware, software, firmware).
• Familiarity with FDA, ISO, EUMDR, IEC 60601, EN ISO 14971, IEC 62304 and EN ISO 13485.
• Strong leadership, relationship building, and team-building skills.
• Travel approximately 5-10%.

Responsibilities

• Lead Quality function for product development teams within the Quality System to develop new Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES).
• Provide quality and compliance inputs to project decisions and deliverables (Design Change Analysis; Design Inputs, Design Outputs; Test Method Development and Validation; Design Reviews; Design Verification and Validation; Usability Testing; SW Validation; Process Validation; and Labeling).
• Provide quality and compliance inputs for post-market sustaining activities (NCEP; CAPAs; PIRs; Field Signals Evaluations and Field Actions).
• Lead Risk Management processes for new products with inputs from cross-functional teams (RMP, RM Report, Risk/Benefit Analysis, Hazards Analysis, dFMEA, pFMEA).
• Engagement with project teams for Systems Engineering and Systems Risk Management as SME.
• Lead NPD projects as a DQA SME reviewing hardware/software architectures for failure modes and risk controls.
• Collaborate to identify and implement controls to meet requirements.
• Maintain compliance to quality requirements and support audits.
• Other duties as necessary.

Skills

Leadership

Quality Assurance

Regulatory Knowledge

Communication

Risk Management

Mentoring

Education

BS in Biomedical or Electrical Engineering

Job description

Boston Scientific in Waltham, MA is seeking a Principal Design Quality Assurance Engineer for the Electrophysiology portfolio. You will lead quality activities across new product development and sustaining projects, building robust quality engineering methods to meet regulatory requirements.

The role emphasizes collaboration, risk management, design verification/validation, and support for internal and external audits.