Job Description
Must-Have Skills
- 10+ years of experience in Medical Device Hardware Development
- Analog, Digital & Mixed-Signal Design
- MCU, FPGA, Sensor Interface Design
- Power Electronics, Battery-Powered Devices, DC-DC Converters
- High-Speed PCB Design (Ethernet, USB, SPI, I2C, CAN)
- PCB Design, DFM, DFT, SI/PI Analysis
- CAPA, Client, Change Control & Obsolescence Management
- Component Qualification & Alternate Part Evaluation
- Hardware Verification & Validation (V&V)
- Risk Management (dFMEA, pFMEA, sFMEA)
- Requirement Traceability (RTM)
- IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485
- FDA Medical Device Regulations
- Manufacturing Transfer & Sustaining Engineering
- Windchill / Agile PLM
- IVD / Clinical Diagnostics / Medical Equipment
- Cost Reduction, VAVE & Should-Cost Analysis
- Safety & EMC Compliance Testing
- Supplier Qualification & Product Lifecycle Management
- Agile / Scrum Project Execution
- Lead hardware design, development, and sustaining engineering activities for regulated medical devices.
- Drive CAPA, change management, obsolescence mitigation, and product improvement initiatives.
- Perform schematic reviews, component selection, PCB design reviews, and hardware validation.
- Execute risk assessments, V&V, compliance testing, and regulatory support activities.
- Support manufacturing transfers, supplier changes, and cost optimization programs.
- Collaborate with Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing teams.
Numbers & Facts
| Location | Tarrytown, NY |
| Industry | Computer Software |
| Company Size | 20 to 49 employees |
| Year Founded | 2014 |
| Website | http://www.tekfortune.com/ |
About Company
Tekfortune is a software solutions company providing project development and staff augmentation services to companies in various industries including Healthcare, Banking, Finance, Telecommunication and Aviation.
Tekfortune Inc delivers solutions to a wide variety of organizations of various sizes and industries. Our clients include mid-market to Fortune 1000 companies spanning across industries such as: Insurance, Financial, Pharmaceutical, Manufacturing, Retail and many others.
In Tekfortune Inc, we are offering selection of services and solutions at very reasonable rates. With years of experience in the placement and recruitment Industry and over time we have acquired the knowledge essential to comprehend the exact need and dependence on customers. Therefore we provide the customers the best and also the brightest candidates for vacancies. Moreover, by understanding the working interest of customers who is able to place them within the companies where they are able to get maximum opportunity for professional growth.
Tekfortune Inc has a strong emphasis on quality. Its goal would be to achieve client satisfaction by looking into making deliveries satisfaction of customer's business needs. Our ability to quickly identify and effectively employ proven fundamental principles, techniques and resources yields highly desirable results for our clients.
We understand that each industry and organization share a level of uniqueness that requires a tailored approach in order to deliver specific solutions. Such factors as client culture, industry regulations, organizational maturity, financial health and many more items may impact our approach to delivering client solutions.
Having served a wide variety of clients has provided Tekfortune the ability to build subject matter expertise across numerous industries. Our industry expertise combined with our specialized knowledge of Business Process Improvement, Requirements Management and Program & Project Management provides a powerful combination and a tremendous value to our clients.
We are run by a group of industry experts who have decades of experience in delivering custom solutions to our clients.
Tekfortune Inc delivers solutions to a wide variety of organizations of various sizes and industries. Our clients include mid-market to Fortune 1000 companies spanning across industries such as: Insurance, Financial, Pharmaceutical, Manufacturing, Retail and many others.
In Tekfortune Inc, we are offering selection of services and solutions at very reasonable rates. With years of experience in the placement and recruitment Industry and over time we have acquired the knowledge essential to comprehend the exact need and dependence on customers. Therefore we provide the customers the best and also the brightest candidates for vacancies. Moreover, by understanding the working interest of customers who is able to place them within the companies where they are able to get maximum opportunity for professional growth.
Tekfortune Inc has a strong emphasis on quality. Its goal would be to achieve client satisfaction by looking into making deliveries satisfaction of customer's business needs. Our ability to quickly identify and effectively employ proven fundamental principles, techniques and resources yields highly desirable results for our clients.
We understand that each industry and organization share a level of uniqueness that requires a tailored approach in order to deliver specific solutions. Such factors as client culture, industry regulations, organizational maturity, financial health and many more items may impact our approach to delivering client solutions.
Having served a wide variety of clients has provided Tekfortune the ability to build subject matter expertise across numerous industries. Our industry expertise combined with our specialized knowledge of Business Process Improvement, Requirements Management and Program & Project Management provides a powerful combination and a tremendous value to our clients.
We are run by a group of industry experts who have decades of experience in delivering custom solutions to our clients.
Skills
- Agile PLM / Oracle PLM (Product Lifecycle Management)unmatched
- Agile Programming Methodologiesunmatched
- Analysis Skillsunmatched
- Change Controlunmatched
- Change Managementunmatched
- Component Selectionunmatched
- Computer Engineeringunmatched
- Computer Firmwareunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cost Analysisunmatched
- Cost Controlunmatched
- DFT (Design for Test)unmatched
- Design Failure Mode and Effects Analysis (DFMEA)unmatched
- Electronicsunmatched
- Ethernetunmatched
- FDA Requirementsunmatched
- FPGAunmatched
- Hardware Designunmatched
- Hardware Developmentunmatched
- I2Cunmatched
- ISO (International Organization for Standardization)unmatched
- International Electro-Technical Commission (IEC)unmatched
- Manufacturingunmatched
- Manufacturing Requirementsunmatched
- Medical Diagnosisunmatched
- Medical Equipmentunmatched
- Microcontrollerunmatched
- Mixed Signal IC Designunmatched
- Printed Circuit Board Designunmatched
- Process Failure Mode and Effects Analysis (PFMEA)unmatched
- Process Improvementunmatched
- Product Lifecycle Managementunmatched
- Product Programsunmatched
- Project Executionunmatched
- Regulatory Complianceunmatched
- Risk Analysisunmatched
- Risk Managementunmatched
- Safety Complianceunmatched
- Schematicsunmatched
- Scrum Project Management and Software Developmentunmatched
- System Integration (SI)unmatched
- Traceabilityunmatched
- USBunmatched
- V&V Testingunmatched
- Validation Testingunmatched
- Windchill PLM Softwareunmatched
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