Manager, Systems Engineering (Medical device development)

Requirement:

• Lead the implementation of a multi-year functional strategy for the Systems Engineering team in alignment with broader R&D and engineering strategies to support the clinical diagnostics product roadmap.
• Enhance existing engineering capabilities in key areas such as Systems Architecture, System Design & Integration, Requirements Management, Configuration Management, Human Factors, Risk Management, Robustness and Reliability, Design for Six Sigma, and Modeling, Analysis, and Simulation.
• Ensure functional excellence across all approved NPD and sustaining programs by identifying and nurturing core team members representing diverse engineering disciplines and broader R&D expertise on project core teams.
• Encourage and guide core team members to maintain the highest standards of Systems Engineering rigor in all project deliverables.
• Implement effective management processes and tools to monitor engineering progress across the entire portfolio of teams.

Qualifications:

• Education: Master's degree in Electrical, Mechanical, Biomedical, or related engineering fields. A PhD or MBA is a bonus.
• Work Experience: Demonstrated track record of 3 years in managing and fostering successful engineering teams that have achieved new product introductions, emphasizing system architecture, modeling & analysis, requirements management, and systems-led product development.
• Minimum 8 years of experience in full product development cycles, with a focus on systems-led design and development of complex integrated solutions (hardware, software, assays) in life sciences/diagnostics or comparable industries, showcasing commercial success.
• 5 years of experience in a regulated industry, preferably clinical diagnostics, with expertise in FDA and global regulatory environments. Strong technical project management skills are essential.
• Exceptional problem-solving, organizational, analytical, and critical thinking abilities, including sound judgment in decision-making and risk management.
• Effective influencer with cross-functional partners, business units, and sites, capable of professional interactions at all organizational levels and adept at escalating issues to appropriate management levels.
• Thrives in a dynamic, fast-paced work environment and consistently delivers results amidst change.

Job Types: Full-time, Contract, Temporary

Pay: $150,000.00 - $200,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Ability to Commute:

• San Francisco Bay Area, CA (Required)

Work Location: In person