Senior Software Engineer

Trudell Medical Group•Elgin, IL

33d

About The Position

The Senior Software Engineer for the Product Development team is responsible for developing and sustaining software controlled electro-mechanical medical devices for minimally invasive surgery. The role will collaborate with Mechanical and Electrical engineers to develop and/or sustain Class I and Class II products that meet the highest standards for accuracy, safety and operating functionality. The Senior Software Engineer may perform both R&D and sustaining engineering activities to launch new products and drive product line extensions and improvements for both OEM customers and our NTI-branded product lines.

Requirements

Bachelor’s Degree in Software Engineering, Electrical Engineering or Biomedical Engineering
A minimum of 4 years of relevant work experience in the medical device field or other highly regulated environment
A minimum of 1 year of Embedded Systems Development
Demonstrated experience creating software to solve problems or meet user needs
Practical experience building, testing, and troubleshooting microprocessor-controlled electromechanical devices
Fluent in C programming, Assembly and other software languages with ability to support migration to Linux for new developments
Experience with communication protocols such as I2C, SPI, RS232, ethernet, Bluetooth, and Wi-Fi with awareness to cybersecurity best practices
Strong software troubleshooting skills and proficiency with debugger applications
Assists in digital transformation of legacy product line to next generation/connected devices, including the identification and adoption of new hardware and software
At least classroom experience with circuits and willingness and ability to learn to test and troubleshoot analog and digital circuitry
Basic understanding of printed circuit board layouts and schematics
Ability to learn and apply new technologies quickly
Experience reading patents and/or drafting invention disclosures
Experience completing Corrective and Preventive Action (CAPA), and willingness and ability to learn FDA Design Controls (FDA 21 CFR 820.30) and FDA 510(k)
Experience with safety risk management and providing FMEA and FTA as required on software/firmware
Excellent written and verbal communications skills
Demonstrated ability to work with other groups and collaborate with others in a team environment
Ability to prioritize effectively and handle shifting priorities professionally
Ability to accurately follow instructions to handle projects independently and work with a high level of independence without continuous supervision
Skilled with Microsoft Office (Word, Excel, PowerPoint, etc)

Responsibilities

Understands and utilizes phase-gated design control process and other control processes throughout the entire product development lifecycle and commercialized product lifecycle
Creates appropriate software architecture and software specifications to meet high level product requirements and applicable standards
Develops, tests and debugs microprocessor-based C and assembly language software based on Software Specifications
Collaborate with an interdisciplinary engineering team through entire product development life cycle, from schematics and breadboards to system prototypes and V&V devices
Creates test protocols and test reports for software verification and validation for new product launches, design changes, and product line extensions
Helps ensure diagnostic and data acquisition software/equipment are adopted where appropriate to fully characterize software
May work closely with internal or customer Marketing dept to come up with ideas and concepts on new product offerings for unmet user needs
Identifies and reports problems to Staff Engineers or Management while providing direction and support to junior engineers
Manage assigned projects from start to finish; for major projects reports to Project Manager or Staff Engineers the scheduling and status of major project subsets
Assists in cross-department or cross-discipline collaborations to solve complex problems
Assists in collaborations with other departments such as Document Control, Manufacturing and Purchasing in the maintenance of software platforms, software installation procedures and commercial release of products
Assists in collaborations with Sales and Marketing as needed to understand user needs for new products and extensions or improvements to existing products
Assists in troubleshooting of non-conformances pertaining to the electronics and software portions of products
May observe surgeries, attend conferences, and plan/lead animal or cadaver labs to better understand user needs and/or test prototypes
Provide support to more junior Software Engineers as needed
Helps ensure all development guidelines and procedure requirements meet FDA and ISO requirements
Develops products in accordance with software lifecycle processes defined in IEC 62304
Assists collaborations with external test agencies, design firms and consultants as appropriate to complete assigned projects
Contribute to a safe work environment by complying with all federal & state laws, Northgate policies, procedures and OSHA, if applicable