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Principal Hardware Engineer

3 months ago

Alpharetta, United States Avanos Full time

Company Description

Job Description

Job Position Purpose / Summary

Avanos is seeking a team-oriented Principal 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.

Job Position 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 architectures, 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. Mentor junior R&D engineers, co-ops or contractors.

Key Relationships / Customer Expectations

(Optional)

Qualifications

Qualifications / Education / Experience / Skill Required

Required Qualifications: Education: Bachelor's degree or Masters in Electrical Engineering or related discipline. Skills / Qualifications:

10-12 years of demonstrated experience in R&D in designing hardware systems for electro mechanical medical device Proven experience of taking concept 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 design phase as well as 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

Preferred Qualifications: Strong understanding of industry best practices, global medical design standards, 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

Physical Demands

(Optional)

A minimum of 10%-30% travel will be required.

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

Additional Information

This document is intended to describe the general nature and level of work to be performed by employees assigned to this position. This document is not intended to be construed as a complete list of all responsibilities, duties, and skills required of incumbents. Management may at any time assign other duties in addition to those listed here, with or without modifying this position description. #J-18808-Ljbffr