Ruth Thon Email & Phone Number

Schönkirchen, Schleswig-Holstein, Germany

- Developing a global bench of diverse talents (~40) capable of driving the innovation pipeline- Providing Design Controls expertise for product development projects from inception through successful Design Transfer- Supporting product supply for our partners in Manufacturing (GQO)- Developing and implementing appropriate product Risk Management strategies and programs to ensure patient safety- Ensuring continual improvement of the efficiency and effectiveness of the quality… Show more - Developing a global bench of diverse talents (~40) capable of driving the innovation pipeline- Providing Design Controls expertise for product development projects from inception through successful Design Transfer- Supporting product supply for our partners in Manufacturing (GQO)- Developing and implementing appropriate product Risk Management strategies and programs to ensure patient safety- Ensuring continual improvement of the efficiency and effectiveness of the quality system meeting industry standards and government regulations- Assisting in facilitation of internal and third-party audits- Serving as delegate to chair the Risk Management Board- Developing plans for integration of new products, transfers, and mergers- Managing global budgets & external resources- Facilitating BestSelf Culture for T&E in Europe Show less

Schönkirchen, Schleswig-Holstein, Deutschland

- Up to 5 direct reports, up to 7 SGTC, up to 20 consultants (Leader of People, Leader of Process & Technical Leads) across US, Europe & India- Falcon Design Control Transformation to increase Speed to Market of new products by leading the following workstreams: Risk Management (WSL), Software Design Control (Sponsor), Product Security (Sponsor)- Building a Digital Quality Organization across 3 Business Units (Trauma, UE, F&A)- 1st Stryker product ISO 27k1 certified Information… Show more - Up to 5 direct reports, up to 7 SGTC, up to 20 consultants (Leader of People, Leader of Process & Technical Leads) across US, Europe & India- Falcon Design Control Transformation to increase Speed to Market of new products by leading the following workstreams: Risk Management (WSL), Software Design Control (Sponsor), Product Security (Sponsor)- Building a Digital Quality Organization across 3 Business Units (Trauma, UE, F&A)- 1st Stryker product ISO 27k1 certified Information Security Management System- Increasing margin by reducing inspection efforts by implemented the new CQA process (NPI & Sustaining)- Efficiency gains by Re-Use of profiles, Risk MAF, automating data (PUMP & NPI Digital)- Developing Talent by fostering a growth environment through Mentoring & Coaching, creating development opportunities, and performance recognition- Guiding and sustaining cultural change Show less

Schönkirchen, Schleswig-Holstein, Germany

- 6 direct reports, 4 direct temps, 5 SGTC, 11 consultants (Project Leaders & Technical Experts) across US, Europe & India- EU MDR WSL Design Quality & Risk Management (Program for initial certification & Periodic Updates across all BUs) - DPO Risk Management, RMB ownership & Representative for T&E Division in Corporate Working Group- Leading through Wright Medical Integration as WSL Risk Management according to ISO 14971 (Harmonization of 7 processes into 1, global roll-out and… Show more - 6 direct reports, 4 direct temps, 5 SGTC, 11 consultants (Project Leaders & Technical Experts) across US, Europe & India- EU MDR WSL Design Quality & Risk Management (Program for initial certification & Periodic Updates across all BUs) - DPO Risk Management, RMB ownership & Representative for T&E Division in Corporate Working Group- Leading through Wright Medical Integration as WSL Risk Management according to ISO 14971 (Harmonization of 7 processes into 1, global roll-out and active conversion of records)- Div. Responsibility for Sustaining: NC-CAPA | RA Support | Audit | PMS | DHF Maintenance | Change Management- Mentoring & Coaching Show less

Schönkirchen, Schleswig-Holstein, Germany

- Up to 5 direct reports (Technical Leaders), Up to 5 consultants (Project Leaders & Technical Experts) across US, Switzerland & Germany- Leading through Wright Medical Integration Planning for Risk Management- Divisional responsibility for Design Quality Assurance- Ownership for Design Control Improvements & Remediations (Usability, Design Validation & Product Security)- DPO Risk Management, RMB ownership & Representative for T&E Division in Corporate Working Group- Review… Show more - Up to 5 direct reports (Technical Leaders), Up to 5 consultants (Project Leaders & Technical Experts) across US, Switzerland & Germany- Leading through Wright Medical Integration Planning for Risk Management- Divisional responsibility for Design Quality Assurance- Ownership for Design Control Improvements & Remediations (Usability, Design Validation & Product Security)- DPO Risk Management, RMB ownership & Representative for T&E Division in Corporate Working Group- Review of Non-Conformities and related Health-Risk & Compliance Risk assessments- Use-as-is and Rework approvals- Successfully facilitated internal and third-party audits of authorities and notified bodies- EU MDR WSL Design Quality & Risk Management for Trauma BU including successful EU-MDR initial certification & Deficiency Management- Clinical Evaluations & EPS Approval Show less

Freiburg, Baden-Württemberg, Germany

- Up to 10 direct reports (Project Leaders & Technical Experts) in Germany- Leading through Campus reorganization- DPO for Electronics Design Control Process & Medical Electrical Equipment Approvals Process- Frequent collaboration with NRTLs & CBTLs in development & complex sustaining projects- Leading Manufacturing audits with CSA for medical electrical equipment- Directive & Standards Management of basic safety, EMC, RF, RoHS- Responsible for Post Market Surveillance… Show more - Up to 10 direct reports (Project Leaders & Technical Experts) in Germany- Leading through Campus reorganization- DPO for Electronics Design Control Process & Medical Electrical Equipment Approvals Process- Frequent collaboration with NRTLs & CBTLs in development & complex sustaining projects- Leading Manufacturing audits with CSA for medical electrical equipment- Directive & Standards Management of basic safety, EMC, RF, RoHS- Responsible for Post Market Surveillance of product line Navigation Platforms- Leading regulatory projects (Freiburg PM): IEC 60601-1 3rd Ed. (x-Div) & RoHS (x-Div & GQO) - Technical Documentation & DHF/DMR Management in Windchill- Sustaining Engineering Show less

Freiburg, Baden-Württemberg, Germany

- Implementation of special development cycle for automated manufacturing tool-system including (SW) process validation & machine qualification- Evidence studies for PreOp Nav project (for 510(k) submission)- Development of Orthopedic Application Software- Tracking accuracy studies for boot navigation & sizing algorithm- Technical support & analysis of feasibility studies- Component- & System test development & execution

Böblingen, Baden-Württemberg, Germany

- Cardiotocography Software & Test development- Algorithm development to extract heart rate from infrared absorption sensors raw data

Master Of Science - Ms, Electrical Engineering & Information Technologies (Major: Medical Devices), Dipl.-Ing. (Master Of Science - Ms)

Electrical And Electronics Engineering, Erasmus Exchange Program