Lead Medical Device Integration Engineer

Katalyst CRO; Chicago (IL); On-site; USD 120,000 - 170,000; Full time

Job summary

Katalyst CRO in Chicago leads complex integration programs for medical devices, requiring a strong background in mechanical/biomedical engineering and regulatory-aware design controls. You will drive cross-functional collaboration, oversee V&V, and manage DHF activities to ensure seamless downstream delivery.

The role emphasizes strategic planning, risk management, and hands-on technical leadership across engineering, quality, and manufacturing teams in a fast-paced, highly collaborative

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related field.
• 6+ years industry experience; 4+ years with an advanced degree.

Responsibilities

• Lead integration workstreams including interface definition, requirements alignment, planning, and technical execution.
• Drive technical decision-making across assigned deliverables in collaboration with engineering leadership.
• Own and ensure completion of design control deliverables including user needs, design inputs/outputs, and traceability.
• Support risk management documentation and mitigation strategy activities.
• Lead verification & validation (V&V) planning and execution activities.
• Support DHF development and maintenance in compliance with regulatory standards.
• Lead or oversee test method development and validation activities to ensure integration readiness.
• Conduct feasibility studies, prototype development, and iterative testing activities to optimize designs across device platforms.
• Perform root cause analysis, resolve complex technical issues, and proactively identify and mitigate integration risks.

Skills

Cross-functional leadership

Requirements management

V&V planning

Design controls

Regulatory knowledge

Problem solving

Education

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field

Advanced degree preferred

Tools

Windchill

Job description

Katalyst CRO in Chicago leads complex integration programs for medical devices, requiring a strong background in mechanical/biomedical engineering and regulatory-aware design controls. You will drive cross-functional collaboration, oversee V&V, and manage DHF activities to ensure seamless downstream delivery.

The role emphasizes strategic planning, risk management, and hands-on technical leadership across engineering, quality, and manufacturing teams in a fast-paced, highly collaborative