Senior Design Quality Engineer

About the role

Boston Scientific is looking for a highly motivated and experienced Senior Quality Engineer to support sustaining engineering activities for commercialized medical devices throughout their lifecycle. The role provides quality engineering expertise for design changes, product investigations, CAPAs and post-market quality activities, working with R&D, Manufacturing, Regulatory Affairs and Post-Market Quality. The position is based in Costa Rica (American Free Zone) with a hybrid model: at least three days per week in the office and the rest remotely.

Key responsibilities

• Support sustaining activities for commercialized medical devices, including design changes, product improvements, quality investigations and cross-functional projects
• Lead and support quality assessments of design changes, including impacts on safety, performance, risk management and regulatory compliance
• Apply design controls such as design requirements, risk management, verification, validation and design history documentation
• Lead and support nonconformance investigations, product impact assessments and CAPA activities
• Evaluate post-market quality information such as complaints and field performance data to identify design-related issues
• Support product risk management, including hazard assessment, risk analysis updates, risk control evaluation and residual risk assessments in line with ISO 14971
• Partner with R&D on verification and validation strategies and provide quality expertise during product investigations and failure analysis
• Review and approve technical documentation and quality records, and mentor engineers on design quality and risk management

Required profile

• Bachelor's degree in Engineering or a related technical discipline
• 5+ years of experience in medical device quality engineering, design quality, sustaining engineering or product engineering
• Experience with commercialized medical devices, including design changes, product investigations or quality improvement
• Experience leading or supporting nonconformance investigations, root cause analysis, NCEPs and CAPAs
• Preferred: Master's degree, experience with active implantable devices or neuromodulation systems, and experience analyzing post-market quality data

Required skills

• Working knowledge of design controls, risk management and quality system requirements (ISO 13485, ISO 14971, FDA regulations)
• Strong analytical problem-solving, decision-making and communication skills, able to work independently and manage competing priorities