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, NCR, 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
Key Responsibilities
- 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.
Skills Required
- 10+ years of experience in medical device hardware development
- Analog, digital, and mixed-signal design experience
- MCU, FPGA, and sensor interface design experience
- Power electronics, battery-powered devices, and DC-DC converter experience
- High-speed PCB design experience with Ethernet, USB, SPI, I2C, and CAN
- PCB design, DFM, DFT, and SI/PI analysis experience
- CAPA, NCR, change control, and obsolescence management experience
- Component qualification and alternate part evaluation experience
- Hardware verification and validation experience
- Risk management experience including dFMEA, pFMEA, and sFMEA
- Requirement traceability management experience
- Knowledge of IEC 60601-1, IEC 60601-1-2, ISO 14971, and ISO 13485
- Knowledge of FDA medical device regulations
- Manufacturing transfer and sustaining engineering experience
- Windchill or Agile PLM experience
What We Do
We started the organization with a vision of some of the top technology professionals in the industry to carve a niche for the next generation solutions as well provide that breeze of fresh air in emerging technology which will help our client think out of the box and provide rapid go to market solutions . The complex technology solutions and global multilingual programs roll out have been hall mark of success for our team. Our key team members are all hands on professional who have the vision and experience of having grown and developed the business from scratch. The have been the guiding power and light behind taking the company to the next level. The management of the organization has an average of over 20 years of experience in starting and running IT companies in the J2EE segment and ERP segment in North America , Australia , EMEA and Europe. The management actively guides the company to make strategic decisions and move forward and make the right decisions . We provide path breaking solutions and consultants who will fit, meet and exceed your requirements. Our focus is primarily in SAP, Oracle, IBM and MS technologies with expertise in technology verticals like cloud, big data and mobility. SAPSOL Technologies Inc . is currently funded by private investment from our management and some external investors. We are open to innovative proposals as well as funding the next generation of solutions for other start-up companies who have a great idea but are unable to leverage
