Systems Engineer II

Roche • Carlsbad, CA

292d • $72,500 - $135,500

About The Position

As a member of our R&D team, the Systems Engineer will assist in the development and implementation of systems engineering methodologies, including requirements gathering, system architecture design, and solution implementation under the guidance of senior engineers. You will participate in ensuring compliance with IVD standards through support roles in various projects and will provide an understanding of the system lifecycle process. You will work effectively within cross-functional teams including R&D, Marketing, Operations, Quality, and Regulatory; ensuring clear and concise communication with team members and stakeholders to support project objectives and regulatory compliance. You will assist / provide support to gather and analyze customer requirements to support the alignment of technical solutions with customer needs and market demands; participate in stakeholder meetings to help prioritize project features and enhancements. You will support the identification and analysis of technical challenges; collaborate with team members to present multiple solution paths and provide detailed information to help stakeholders make informed decisions.

Requirements

• Bachelor's in Systems Engineering, Engineering, Biomedical Sciences, or a related technical field.
• 3+ years Systems Engineering experience in an R&D organization within the in-vitro diagnostics or medical device industry.
• Strong scientific knowledge and assay development experience.
• Demonstrated understanding of systems engineering principles.
• Experience with application/product lifecycle management software (e.g., DOORS, Hp ALM, Retina).
• Ability to take accountability for tasks and be proactive within a team.
• Strong collaboration and communication skills.

Nice To Haves

• Familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products.
• Excellent organizational skills.
• Ability to efficiently evaluate, prioritize and handle multiple changing projects.

Responsibilities

• Assist in the development and implementation of systems engineering methodologies.
• Participate in ensuring compliance with IVD standards.
• Work effectively within cross-functional teams.
• Gather and analyze customer requirements.
• Participate in stakeholder meetings to prioritize project features.
• Support the identification and analysis of technical challenges.
• Collaborate with team members to present multiple solution paths.

Benefits

• Discretionary annual bonus based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree