Senior Design QA Engineer, Electrophysiology (Hybrid)

Boston Scientific Corporation; Arden Hills (MN); Hybride; USD 85 000 - 162 000; Plein temps

Résumé du poste

Boston Scientific Corporation seeks a Senior Design Quality Assurance Engineer for the Electrophysiology portfolio. The role leads quality engineering for sustaining projects and establishes quality systems to meet regulatory requirements.

Hybrid work in Arden Hills, MN requires on-site presence at least three days per week. You will drive compliance activities across design verification/validation, testing, risk management and CAPA while partnering with cross-functional teams to ensure patient

Qualifications

• Bachelor’s of Science in Biomedical, Electrical Engineering or equivalent.
• 6 years of medical device engineering experience, with MEE/MES experience.
• Experience in design verification and validation of Capital Equipment (hardware, software, firmware).
• Regulated environment exposure (FDA, ISO, EUMDR, IEC 60601, EN ISO 14971, IEC 62304, EN ISO 13485).
• Strong leadership, relationship building and team building skills.
• Strong communication and presentation skills.
• Strong applied knowledge of statistical concepts, tools, and methodologies.
• Travel approximately 5-10%.

Responsabilités

• Lead Quality function for product sustaining teams within the Quality System for Medical Electrical Equipment and SUD as part of DQA engineers.
• Provide quality and compliance inputs to project teams for decisions and deliverables (e.g., Design Change Analysis; Design Inputs/Outputs; Test Method Development and Validation; Design Reviews; Verification and Validation; Usability Testing; SW Validation; Process Validation; Labeling).
• Support post market product sustaining activities (non-conformances; CAPA; PIRs; Field Actions).
• Create and maintain safety risk management processes (Hazard Analysis, FTA, Use Error Analysis, Risk Management Plan/Report, DFMEA).
• Collaborate within teams to implement controls meeting internal and external requirements.
• Build quality into all work; maintain compliance with quality requirements.
• Support internal/external regulatory audits as required.
• Other duties as needed.

Connaissances

Leadership

Communication

Statistics

Regulatory knowledge

Travel

Formation

BS in Biomedical or Electrical Engineering

Description du poste

Boston Scientific Corporation seeks a Senior Design Quality Assurance Engineer for the Electrophysiology portfolio. The role leads quality engineering for sustaining projects and establishes quality systems to meet regulatory requirements.

Hybrid work in Arden Hills, MN requires on-site presence at least three days per week. You will drive compliance activities across design verification/validation, testing, risk management and CAPA while partnering with cross-functional teams to ensure patient