Suttons Creek, Inc.

• Serve as technical lead or system quality engineering authority for drug delivery combination product programs. • Guide architecture development, requirements management, system integration, and risk mitigation. • Lead technical discussions with internal teams and pharmaceutical partners to ensure alignment of requirements and design intent. • Develop and review quality systems/design control deliverables to document compliance with medical device development processes. • Ensure compliance with ISO 13485, ISO 14971, 21CFR 820.30, and applicable combination product regulations. • Act as Subject Matter Expert, reviewer, or approver for controlled documents within your technical domain. • Prepare detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria • Establish and maintain project timelines, deliverables, and budgets ensuring successful program execution. • Align program execution with industry standards, external regulatory requirements and site quality management systems • Apply regulatory and quality requirements to ensure patient safety and product performance.