Design Quality Engineer II (Defined Term) - Hybrid

Boston Scientific Gruppe; San Jose (CA); Híbrido; USD 82 000 - 155 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Paid vacation

401K matching

Healthcare benefits

Resumo da oferta

Boston Scientific is seeking a Design Quality Engineer II for a defined-term up to 24 months in the Neuromodulation division. The role supports design activities, risk management, and post-market surveillance on cross-functional teams, with a hybrid on-site/remote work model in the San Jose area.

The ideal candidate holds an engineering degree, has 2+ years in medical device quality or design, and can solve complex problems using data, analysis, and statistics while collaborating across

Qualificações

• Bachelor’s degree in mechanical, industrial, electrical, or biomedical engineering or related technical discipline.
• Minimum of two years of professional experience in manufacturing, design, risk management, design assurance, post-market quality, and/or design engineering.
• Experience in medical device industry or similar highly-regulated industry.
• Ability and willingness to work in a defined-term role for up to 24 months.
• Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics.
• Strong communication and analytical skills.
• Ability to effectively work and collaborate in a mixed onsite and remote environment.
• Demonstrated cross-functional teamwork in a technically demanding environment.
• Ability to travel up to 10%

Responsabilidades

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Act as an effective team member and mentor in supporting quality disciplines, decisions, and practices
• Work within a cross-functional team to identify and implement effective controls and support integration of design control related products, records, and processes
• Own, create, maintain, and/or support safety risk management processes, including Hazard Analysis, Risk Management Plan, Risk Management Report, and DFMEA
• Support Post-Market activities, as necessary, of risk based on post-market signals
• Consult with product experts, design engineering, post-market quality, and medical safety functions in a highly cross-functional organization for risk analysis across the life of Boston Scientific Neuromodulation products
• May provide support to Design Quality Engineers on new product development, acquisitions, and sustaining engineering projects
• Perform quality trending using the complaint and NCEP/CAPA systems; perform and/or lead risk analyses for CAPA and/or audit findings investigations
• Serve as a good team member, fully motivated to achieve and demonstrate best practices in line with the division’s objectives

Conhecimentos

Strong communication

Analytical skills

Team collaboration

Formação académica

Bachelor’s degree in mechanical, industrial, electrical, or biomedical engineering

Ferramentas

ISO 13485 knowledge

Design Controls

Quality System Regulations

DFMEA/Risk Analysis

Descrição da oferta de emprego

Boston Scientific is seeking a Design Quality Engineer II for a defined-term up to 24 months in the Neuromodulation division. The role supports design activities, risk management, and post-market surveillance on cross-functional teams, with a hybrid on-site/remote work model in the San Jose area.

The ideal candidate holds an engineering degree, has 2+ years in medical device quality or design, and can solve complex problems using data, analysis, and statistics while collaborating across