Christian Bruderer

Senior Project Lead Medical Device @ Brütsch Technology

About

Strong experience in regulated medical industry (ISO 13485, MDR, US regulations). Strong experience in design control and documentation. Strong experience in new product development, life-cycle-management and change control Strong experience in project lead/management. Strong experience in technical project lead of new product development project, from early development to verification and validation till global launch. Strong experience in team leadership up to ten direct reports. Strong experience in education of Design Engineer apprentices and as final exam expert of apprenticeships. Good experience in Cleaning, Steam Sterilization and Gamma Sterilization. Good experience in Packaging validations.

Country

Switzerland

City

Winterthur

Industry

Medical Device

Skill

Medical Devices, FMEA, Quality System, Product Development, Design for Manufacturing, FDA, Engineering, R&D, Design of Experiments, Orthopädie, CAPA, Reverse Engineering, Abteilungsübergreifende Teamführung, Cross-functional Team Leadership, Ingenieurwissenschaften, ISO 13485, Medizinprodukte, Produkteinführung, Produktentwicklung, Validation

Experience

Senior Project Lead Medical Device

Brütsch Technology

2024-2 - Present · 2 yrs 8 mos

Beringen, Schaffhausen, Schweiz

Lead Medical Device Engineer / Quality Manager

STIMIT AG

2021-11 - 2024-1 · 2 yrs 3 mos

Head Design Engineering & Technical Integration

Nobel Biocare

2020-8 - 2021-10 · 1 yr 3 mos

Zürich und Umgebung

Head Design Engineering Implant Systems

Nobel Biocare

2016-12 - 2020-8 · 3 yrs 9 mos

Zürich und Umgebung, Schweiz

Line Management activities Ressource planning Recruiting Cross-functional Project Lead Project Management Technical Project Lead CAPA Design Control Risk Management Validations Verifications

Product Development Engineer

Nobel Biocare

2014-10 - 2016-11 · 2 yrs 2 mos

Kloten-Balsberg

New product development Packaging validations Cleaning, disinfection and sterilization validations for reprocessing devices Design control Risk assessment/management CAPA Voice of Customer

Development Engineer

Johnson & Johnson MedTech

2014-1 - 2014-9 · 9 mos

Oberdorf BL

New product development of implants for thoracic fixation (plates and screws). Responsible for verification and validation activities of new products according to MDD 93/42/EWG and for FDA-510(k). Remediation activities and CE-marking documentation update.

CAD Engineer

Zimmer Biomet

2005-3 - 2013-12 · 8 yrs 10 mos

Winterthur

Department Research: Selbstständiges Durchführen von Teilprojekten für die Testung von Implantaten Selbstständiges Konstruieren von Testaufbauten für die Testung von Implantaten Vergabe von Fertigungsaufträgen Qualitäts- und Funktionskontrolle Reverse Engineering Erstellen von 3D-Modellen aus MRI/CT-Daten Department Development Extremities: 3D Modellieren von Implantaten und Instrumenten Erstellen der Produktionszeichnung Funktionalitätsanalysen für Verifizierung der Designs durchführen Validierungsaktivitäten bei Wetlabs und Sawbone Workshops Mitverantwortlich für die Erfüllung der regulatorische Ansprüche nach MDD 93/42/EWG

CAD Designer/Konstrukteur in Medizintechnik

Zimmer Biomet

1997-3 - 2001-6 · 4 yrs 4 mos

Winterthur

Entwicklung von Instrumenten und Implanten für Orthopädie (NPD and PME) Verantwortlich für die Bestellung sowie für die Funtions- & Qualitätskontrolle von Prototypen Einhalten der regulatorischen Ansprüche auf Zeichnungsebene