Design Assurance Engineer (f/m/d)

Genedata seeks a Design Assurance Engineer for an on-site role in Grens, Switzerland. The position involves quality assurance for new product implementations, manufacturing transfers, and related projects within the Quality Department.

The Design Assurance Engineer supports quality assurance activities for new product implementations and manufacturing transfers. This role is based in Grens, Switzerland, and requires on-site presence within the Quality Department.

Responsibilities

• Provide quality support and coordinate collaboration with third parties for new product introductions and manufacturing transfers.
• Develop and maintain detailed change control strategies and documentation, reviewing technical specifications and design documents for feedback.
• Assist in creating, implementing, and improving manufacturing processes and quality systems.
• Draft, review, and approve site documentation to ensure alignment with quality management system (QMS) standards.
• Propose solutions to site-related issues to maintain consistent project execution.
• Create process improvement plans using tools such as Process Mapping, Six Sigma, Lean Manufacturing, 5S, SPC, RCA, DOE, and Gauge R&R.
• Identify and report EHS, quality, or compliance issues, taking immediate corrective or escalation actions as needed.

Requirements

• Bachelor’s degree or higher in engineering, health sciences, or a related field.
• Minimum 2-3 years of experience in ISO 9001, medical device, or pharmaceutical industries in engineering, quality, regulatory, or R&D roles.
• Proven knowledge of product development lifecycles, design and document change control, validation methods, and manufacturing process controls in a medical device setting.
• Ability to interpret technical drawings, journals, and procedures.
• Strong QA process knowledge with technical skills to understand device/instrument hardware and software; experience with single-use disposable kits is beneficial.
• Proficiency in Microsoft tools including Word, Excel, PowerPoint, Project, Minitab, and Visio.
• Excellent verbal, written, and presentation skills in both English and French (spoken and written).

Nice to have

• Experience with single-use disposable kits.

About the company

The company fosters a culture of belonging where individual perspectives are valued. It leverages continuous improvement to drive innovation and impact, focusing on meaningful challenges with supportive teams dedicated to customers and patients.

• A culture of belonging where your unique viewpoint matters.
• Innovation driven by continuous improvement and real-world impact.
• Opportunities for personal and professional growth while working on meaningful challenges.
• A collaborative team environment focused on advancing science and technology for patient benefit.