Design Assurance Engineer – Quality & Manufacturing

About the role

Cytiva is seeking a Design Assurance Engineer to support new product introductions, manufacturing transfers and quality assurance projects. Based on‑site in Grens, Switzerland, you will work within the Quality Department to ensure products meet rigorous medical‑device and pharmaceutical standards.

Key responsibilities

• Provide quality support and coordinate collaboration programs with third parties, NPIs and manufacturing transfer projects.
• Create detailed change‑control strategies and maintain comprehensive records.
• Review requirements, specifications and technical design documents, delivering timely feedback.
• Support development, implementation and continuous improvement of manufacturing processes and Quality Management Systems.
• Write, review and approve site documentation to ensure QMS compliance.
• Identify site problems, propose solutions and ensure consistent project execution.
• Develop process‑improvement plans using tools such as Process Mapping, Six Sigma, Lean Manufacturing, 5S, SPC, RCA, DOE and Gauge R&R.
• Report EHS, quality or compliance concerns and take corrective action or escalation as needed.

Required profile

• Bachelor’s degree or higher in engineering, health sciences or a related field.
• 2–3 years of experience in an ISO 9001‑certified medical‑device or pharmaceutical environment, in engineering, quality, regulatory or R&D roles.
• Strong understanding of product development lifecycles, design change, document control, verification/validation and manufacturing process control.
• Ability to read and interpret technical drawings, specifications and procedures.

Required skills

• Process Mapping
• Six Sigma
• Lean Manufacturing
• 5S
• Statistical Process Control (SPC)
• Root Cause Analysis (RCA)
• Design of Experiments (DOE)
• Gauge R&R
• ISO 9001 / QMS knowledge
• Change‑control and validation methodologies