Tom Silka Email & Phone Number

Chicago, Il, Us

Cary, Illinois, United States

Troy, Michigan, United States

Troy, Michigan, United States

Troy, Michigan, United States

Birmingham, Mi

Advanced Pressure Injury Visualization System (Class I Device)- Clinical Manager for a department of licensed nurses and field service technicians supporting Wellsense products installed in hospital ICU’s across the United States. Support of clinical sites require a unique balance of technical, clinical and sales/marketing elements.- Quality Manager responsible for spearheading the creation of the corporate quality system, including the creation of SOP’s, complaint/RMA handling, MDR… Show more Advanced Pressure Injury Visualization System (Class I Device)- Clinical Manager for a department of licensed nurses and field service technicians supporting Wellsense products installed in hospital ICU’s across the United States. Support of clinical sites require a unique balance of technical, clinical and sales/marketing elements.- Quality Manager responsible for spearheading the creation of the corporate quality system, including the creation of SOP’s, complaint/RMA handling, MDR reporting, supplier controls, and supporting audit activity. - Core team member and management representative supporting an international Engineering team in Israel. Show less

Novi, Mi

Breast Cancer Ultrasound Imaging Device (Class II Device)- Manager for all corporate activities related to design concept, design transfer, part procurement, supply chain, inventory, and manufacturing of designs from prototype to commercialization.- Leader for a team of engineers and suppliers to support corporate design and manufacturing goals.- Led the successful execution of the commercial pilot build.

Novi, Mi

- Lead engineer for all design transfer activities to contract manufacturers of designs from prototype to commercial design.- Lead engineer for the pre-production and commercial builds of all devices in existence.- Authored numerous mechanical and electrical assembly work instructions.- Authored Process FMEA.

Plymouth, Mi

- Lead engineer on all Design Validation activities.- Authored numerous standard operating procedures to establish an ISO 13485 compliant Quality System.- Established an ISO 17025 compliant calibration program for over fifty assets.- Determined EU Directive Compliance (RoHS2, China RoHS, REACH, WEEE) to over twelve hundred individual device components.- Authored all Design Validation Protocols and Reports.- Authored all risk documentation (Risk Management Plan & Report… Show more - Lead engineer on all Design Validation activities.- Authored numerous standard operating procedures to establish an ISO 13485 compliant Quality System.- Established an ISO 17025 compliant calibration program for over fifty assets.- Determined EU Directive Compliance (RoHS2, China RoHS, REACH, WEEE) to over twelve hundred individual device components.- Authored all Design Validation Protocols and Reports.- Authored all risk documentation (Risk Management Plan & Report, Hazard Analysis, Design FMEA, Application FMEA) compliant to ISO 14971. Oversaw creation of Software Hazard Analysis documents. - Created and maintained all system Device History Record’s.- Determined device compliance through objective evidence for various IEC electrical safety, ultrasound and medical device industry standards.- Assisted in providing supporting documentation for Design History Files and 510k submissions to the FDA. Show less

Ann Arbor, Mi

Endoscopic Vessel Harvesting / Cannula & Catheter / Blood Monitoring (Class II & III Devices)- Maintain and follow proper ISO 13485, ISO 14971 standards, GMP – 21 CFR Part 11, Part 820, other FDA requirements and ensure compliance to Terumo quality policies.- Authored Risk Management Plan & Reports, Hazard Analysis, Design, Process, User and Software FMEA’s of assorted Electro-Mechanical, Cannula & Catheter and CDI™ blood monitoring product lines.- Authored Design Verification… Show more Endoscopic Vessel Harvesting / Cannula & Catheter / Blood Monitoring (Class II & III Devices)- Maintain and follow proper ISO 13485, ISO 14971 standards, GMP – 21 CFR Part 11, Part 820, other FDA requirements and ensure compliance to Terumo quality policies.- Authored Risk Management Plan & Reports, Hazard Analysis, Design, Process, User and Software FMEA’s of assorted Electro-Mechanical, Cannula & Catheter and CDI™ blood monitoring product lines.- Authored Design Verification, Validation and Reliability plans, protocols, and reports for prototype evaluations on cadaver and animal test subjects. - Extensive knowledge of IEC 60601-1. Directly involved in compliance remediation.- Core team member for the successful launch of the VirtuoSaph Plus™ EVH System project in co-development with international supplier (Japan).- Traveled to Japan on multiple occasions to negotiate Quality System and Design Control issues and assist in executing an APQP audit. - Provided supporting documentation for Design History Files, clinical trials and 510k submissions to the FDA. Show less

Ann Arbor, Mi

VirtuoSaph™ Endoscopic Vein Harvesting System (Class II Device)- Responsible for investigating and responding to all in-plant non-conformances and customer complaints for the VirtuoSaph™ EVH product line.- Work directly with engineers to prepare HA’s / FMEA’s on all quality issues.- Provide a Sustaining Engineer role to lead and resolve quality issues through properly allocating resources and executing a resolution by a deadline.- Provide Product Development with data and… Show more VirtuoSaph™ Endoscopic Vein Harvesting System (Class II Device)- Responsible for investigating and responding to all in-plant non-conformances and customer complaints for the VirtuoSaph™ EVH product line.- Work directly with engineers to prepare HA’s / FMEA’s on all quality issues.- Provide a Sustaining Engineer role to lead and resolve quality issues through properly allocating resources and executing a resolution by a deadline.- Provide Product Development with data and assistance during the research and development of specific products.- Monitor quality issue metrics to implement Corrective and Preventive Actions (CA/PA). Data is presented to Quality and Executive Management.- Worked with Japan and Germany suppliers to establish manufacturing process flow charts, communicate all quality issues.- Became certified as an internal auditor in November 2007. Show less

Dearborn, Mi

Livonia, Mi

Master Of Business Administration - Mba, Healthcare Leadership

The Oakland University School of Business Administration is dual AACSB accredited for business and accounting. Less than five percent.

Master Of Science - Ms, Biomedical Engineering

Concentration in Impact Biomechanics, Human Injury Tolerance and Project Management

Bachelor Of Science - Bs, Mechanical Engineering

High School Diploma