Lead Medical Device Integration Engineer

Katalyst CRO; Dexter (MI); Vor Ort; USD 90.000 - 140.000; Vollzeit

Zusammenfassung

Katalyst CRO in Dexter, Michigan, seeks an integration-focused engineer to lead cross-functional workstreams across design controls and quality systems for medical device platforms. You will drive interface definitions, requirements alignment, and regulatory-compliant DHF activities, collaborating with engineering, quality, and regulatory teams.

The role emphasizes V&V planning, test method development, and proactive risk mitigation in a highly collaborative environment.

Qualifikationen

• Bachelor's degree in Mechanical, Biomedical, Materials Science or related field.
• Advanced degree preferred for senior level roles.
• Strong experience in medical device development within a design controls environment.

Aufgaben

• Lead integration workstreams including interface definition, requirements alignment, planning, and technical execution.
• Drive technical decision-making across assigned deliverables 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 and validation planning and execution activities.
• Support DHF development and maintenance in regulatory compliance.
• Lead or oversee test method development and validation activities for integration readiness.
• Conduct feasibility studies, prototype development, and iterative testing across device platforms.
• Perform root cause analysis and mitigate integration risks.
• Collaborate with quality, manufacturing, supplier engineering, and regulatory teams to drive execution.

Kenntnisse

Technical leadership

Cross-functional collaboration

Communication

Problem solving

Ausbildung

Bachelor's degree in Mechanical Engineering or Biomedical Engineering or Materials Science

Advanced degree preferred

Tools

Windchill

PLM/quality systems

V&V tools

Jobbeschreibung

Katalyst CRO in Dexter, Michigan, seeks an integration-focused engineer to lead cross-functional workstreams across design controls and quality systems for medical device platforms. You will drive interface definitions, requirements alignment, and regulatory-compliant DHF activities, collaborating with engineering, quality, and regulatory teams.

The role emphasizes V&V planning, test method development, and proactive risk mitigation in a highly collaborative environment.