Lead Design QA Engineer — Medical Devices (Hybrid)

Boston Scientific; Arden Hills (MN); Hybrid; USD 102,000 - 194,000; Full time

Benefits offered by this job

Hybrid work model

Competitive compensation

Job summary

Boston Scientific is seeking a Principal Design Quality Assurance Engineer to lead sustaining projects for Electrophysiology cardiovascular products. You will develop and maintain quality-engineering methodologies to meet regulatory requirements.

The role is hybrid, based in Arden Hills, MN, on-site at least three days weekly. Requires 10+ years in medical devices and strong leadership and communication skills.

Qualifications

• BS in Biomedical, Electrical Engineering or equivalent.
• 10 years of medical device engineering experience (MEE/MES).
• Experience in design verification/validation of Capital Equipment (HW/SW).
• Regulated environment experience (FDA, ISO, EUMDR, IEC 60601, EN ISO 14971, IEC 62304, EN ISO 13485).
• Strong leadership, mentoring and risk-based decision making.

Responsibilities

• Lead Quality function for product sustaining teams within MEE/MES as part of a core DQA group.
• Provide quality inputs for project decisions and deliverables (DCA, DV/CV, V&V, Usability).
• Support post-market activities (NCEP, CAPA, PIRs, field actions).
• Lead safety/risk management activities (Hazard analysis, DFMEA, Risk Management Plan).
• Mentor design assurance team and coach R&D on risk-based decisions.

Skills

Quality Assurance

Medical devices

Risk management

Leadership

Communication

Statistical methods

Education

Bachelor's of Science in Biomedical or Electrical Engineering or equivalent

Job description

Boston Scientific is seeking a Principal Design Quality Assurance Engineer to lead sustaining projects for Electrophysiology cardiovascular products. You will develop and maintain quality-engineering methodologies to meet regulatory requirements.

The role is hybrid, based in Arden Hills, MN, on-site at least three days weekly. Requires 10+ years in medical devices and strong leadership and communication skills.