Senior Hardware Engineer

2 weeks ago

Alpharetta, United States Avanos Full time

Company Description

Job Description

The Role

Senior Hardware Engineer

Position Purpose

Avanos is seeking a team-oriented Senior Hardware Engineer to join the newly established R&D Hardware Engineering team. This position will lead hardware architecture planning, design, and development for new electronic medical devices and support existing product hardware initiatives in all the phases of the product cycle.

Reports to the Manager of Hardware/ Software Engineering

Accountabilities / Expectations / Responsibilities

Be a hardware technical lead on electronic medical device projects, developing hardware architectures and design across the Avanos portfolio. Design and develop electronic hardware architecture, PCBs, and schematics using Altium or equivalent CAD tools and board bring up. Guide PCB layout Implement best DFM practices. Program FPGAs or microcontrollers to collect/organize data from various ICs/sensors via any manner of serial/parallel communication protocols (e.g., SPI, I2C, USB, 8b10b) and disseminate that data in a multitude of ways (e.g., serial outputs such as USB, UART, biphase) Build test fixtures, automate testing, and iterate/troubleshoot prototypes. Develop test plans and support Verification and Validation activities. Document hardware architecture, design descriptions, test protocols and reports. Support risk management activities (Hazards Analysis, UFMEA, DFMEA, etc.) Provide technical support for sustaining changes to commercialized products for any hardware needs. Present technical updates to senior leadership in a clear and effective manner. Support technical diligence activities as part of broader M&A initiatives. Work in a highly collaborative environment with cross-functional teams such as software, firmware, commercial teams, systems, and vendors. Work closely with a mix of internal resources and external vendors (contract manufacturers, design firms, etc.). Balance technical complexity, standards and regulations, stakeholder needs and project timelines.

Qualifications

Qualifications

Required

Solid experience in R&D in designing hardware systems for electromechanical medical devices Bachelor's degree or Masters's in Electrical Engineering or related discipline. 5+ years of demonstrated experience in R&D in designing hardware systems for electromechanical medical devices. Proven experience of taking concepts from prototype to product launch. Proficient in PCB design and CAD simulation tools, LabView, Python, or similar platforms for testing. Experience working with internal and external manufacturers both in the design phase as well as the design transfer and qualification process. Prior experience executing complex electronic Class II or Class III medical devices. Excellent and demonstratable written and verbal technical communications skills. Experience in medical device EMC and EMI testing. Experience in translating technical requirements and specifications to Verification and Validation protocols. A minimum of 10%-30% travel will be required.

Preferred

Strong understanding of industry best practices, global medical design standards, and relevant FDA guidance (e.g., ISO-13485, IEC-60601, ISO-14971, IEC-62304, IEC-60812, ISO 62366, cybersecurity, etc.). Experience supporting risk management activities (Hazards Analysis, UFMEA, DFMEA, etc.). Strong ability to work with statistical and technical software (MATLAB, Minitab, JIRA, etc.) and Microsoft Office (Word, Excel, PowerPoint, etc.) Six Sigma or Agile Development Certification

This role can be in-person or hybrid. If hybrid, a minimum of 3 days/week will be on-site.

Additional Information #J-18808-Ljbffr

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