Senior R&D Engineer – Neurovascular Medical Devices

Lancesoft; Irvine (CA); Presencial; USD 120.000 - 155.000; Jornada completa

Descripción de la vacante

Lancesoft in Irvine, CA, seeks a Senior R&D Engineer to contribute to Neurovascular (NV) medical devices within the Neuroscience Portfolio. You will ensure compliance with design control, risk management, and regulatory requirements while delivering technical leadership on released products.

Join a cross-functional team and mentor colleagues, author and review engineering docs, lead investigations into nonconformances, and drive continuous improvements in product quality and process performance.

Formación

• Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related engineering discipline. Master’s degree preferred but not required.
• 5 years of relevant engineering experience, preferably within the medical device industry.

Responsabilidades

• Evaluate and implement design, material, supplier, manufacturing, and labeling changes for released products while ensuring compliance with design control, risk management, and regulatory requirements.
• Author, review, and approve engineering documentation including design specifications, risk analyses, test methods, protocols, reports, engineering change orders, and technical assessments.
• Provide technical leadership for commercialized products, including design improvements, obsolescence mitigation, cost-reduction initiatives, and supply continuity projects.
• Lead investigations and engineering rationale related to product nonconformances, complaints, CAPAs, field issues, manufacturing issues, and supplier quality concerns using structured problem-solving methodologies.
• Create protocols, perform data analysis, and author reports to demonstrate that product and process changes meet design intent and regulatory requirements.
• Collaborate with Manufacturing, Quality, Regulatory Affairs, Supplier Quality, Marketing, Clinical, and Operations teams to evaluate product performance and implement effective solutions.
• Assess supplier changes, manufacturing process changes, equipment qualifications, and material modifications to ensure continued product quality and performance.

Conocimientos

Technical leadership

Cross-functional collaboration

Engineering documentation

Problem solving

Regulatory awareness

Educación

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Materials Science

Master's degree preferred

PhD (optional)

Herramientas

Regulatory practices

Descripción del empleo

Lancesoft in Irvine, CA, seeks a Senior R&D Engineer to contribute to Neurovascular (NV) medical devices within the Neuroscience Portfolio. You will ensure compliance with design control, risk management, and regulatory requirements while delivering technical leadership on released products.

Join a cross-functional team and mentor colleagues, author and review engineering docs, lead investigations into nonconformances, and drive continuous improvements in product quality and process performance.