Daniel Ritter Email & Phone Number

Responsible for leading Pre Market Quality, External Supplier Quality, Risk Management and Quality Engineering functions for Neuromodulation and Pelvic Health Operating Units.Lead staff of 8 direct reports with total organization of 43 engineering and technical professionals.

Responsible for leading Post Market Quality, Internal Supplier Quality and Post Market Surveillance functions for Neuromodulation and Pelvic Health Operating Units.Lead staff of 6 people managers and an organization of 30+ managers, program managers and engineers.Responsible for representing product quality in external inspections/audits.Participate as.

• Responsible for organizational execution of all requirements within Neuromodulation Consent Decree
• Lead contact with 3rd party expert for the consent decree for audits and issue resolution
• Represented Neuromodulation in FDA inspection as lead (Front Room lead, CAPA area lead, and 806 reportability expert), in final FDA inspection required per the consent decree. Inspection resulted in zero observations.
• With a staff of 21, department is responsible for CAPA domain, quality data analytics, process validation and regulatory compliance within Neuromodulation, including interfaces with all partnering areas (Risk.

• Responsible for field action process, execution, and regulatory reportability decisionso Negotiated with external regulators on key aspects of field action plans (press releases, scoping, reportability, classification.
• Led service department with staff of 18 and returned product lab with staff of 20o Led department to identify and complete cost savings initiative within 6 months that resulted in 3MM+ annual cost savingso Department.

• Lead team of 9 individuals supporting entire division in CAPA execution
• CAPA Board Chair for division and responsible CAPA oversight decisions
• Defended CAPA process area (QSIT and MDSAP styles) to external and internal auditors, including linkages to other QMS process areas

• Led creation of two brand new CAPA boards
• Developed training for new CAPA owners on CAPA problem solving process and methodology
• Coached CAPA owners across all areas of the business

Responsible for managing multiple, concurrent technology development projects. Projects included research of new features, integration of new components, development of system firmware and software, wireless (900MHz and 2.4 GHz) firmware development, and regulatory support of a 510(k) commercial product. Work with teams composed of cross-functional.

• Provided quality engineering support for both pre and post commercial projects representing multiple suppliers. Product types have ranged from commercial electronics to drug infusion kits and surgical equipment..
• Pulled in a transfer project schedule by 15% to avoid a product stock out
• Reducing process lead times resulting in 200 person hours of time savings per year
• Leading cost reduction initiatives
• Leading a cross functional project team to meet and exceed a deadline set forth by the FDA for specific product updates
• Revising divisional metrics and objectives around the product deviation process

Supported both the Prostiva and InterStim therapies. Work included reviewing design and manufacturing engineering changes for regulatory impact, participating in cross functional creation and review marketing promotional materials, leading a cross functional team to provide inputs to FDA guidance documents, and participating in a core team as the.

Assisted professional equipment engineering project managers in building equipment for a commercial product line. Duties included tracking project deliverables, updating the project schedule, managing capital finances and completing departmental work requests. Other contributions were assisting in revising departmental procedures, tracking project change.

Was assigned a project to evaluate, recommend and implement a technology solution to measure potential contaminants of medical devices. Main focus was comparing multiple technology options and determining the ideal path for a solution. Other duties involved vendor interactions, presentations to management on recommendations and training of professional.

Ms, Mechanical Engineering

Bs, Biomedical/Medical Engineering