Senior R&D Engineer - Medical Devices Design Lead

Planet Pharma; Irvine (CA); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Senior R&D Engineer in the Neurovascular portfolio is a technical contributor within Research & Engineering. This role ensures NV medical devices comply with design control, risk management, and regulatory requirements, providing technical leadership and cross-functional collaboration.

The position emphasizes problem solving, design improvements, and ensuring supply continuity while coordinating with Manufacturing, Quality, Regulatory, and Marketing teams.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Sustaining/Released product eng

Technical investigation

Engineering documentation

Ausbildung

Bachelor’s degree in Mechanical Eng, Biomedical Eng, Materials Science

Master’s degree preferred

Jobbeschreibung

Senior R&D Engineer in the Neurovascular portfolio is a technical contributor within Research & Engineering. This role ensures NV medical devices comply with design control, risk management, and regulatory requirements, providing technical leadership and cross-functional collaboration.

The position emphasizes problem solving, design improvements, and ensuring supply continuity while coordinating with Manufacturing, Quality, Regulatory, and Marketing teams.