Senior Software Engineer

\n 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.
\n Design, Development and Testing

Understands and utilizes phase-gated design control process and other control processes throughout the entire product development lifecycle and commercialized product lifecycle
\n Creates appropriate software architecture and software specifications to meet high level product requirements and applicable standards
\n Develops, tests and debugs microprocessor-based C and assembly language software based on Software Specifications
\n Collaborate with an interdisciplinary engineering team through entire product development life cycle, from schematics and breadboards to system prototypes and V&V devices
\n Creates test protocols and test reports for software verification and validation for new product launches, design changes, and product line extensions
\n Helps ensure diagnostic and data acquisition software/equipment are adopted where appropriate to fully characterize software
\n May work closely with internal or customer Marketing dept to come up with ideas and concepts on new product offerings for unmet user needs
\n Identifies and reports problems to Staff Engineers or Management while providing direction and support to junior engineers

\n Planning, Support, and Collaboration

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
\n Assists in cross-department or cross-discipline collaborations to solve complex problems
\n 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
\n Assists in collaborations with Sales and Marketing as needed to understand user needs for new products and extensions or improvements to existing products
\n Assists in troubleshooting of non-conformances pertaining to the electronics and software portions of products
\n May observe surgeries, attend conferences, and plan/lead animal or cadaver labs to better understand user needs and/or test prototypes
\n Provide support to more junior Software Engineers as needed

\n Regulatory

Helps ensure all development guidelines and procedure requirements meet FDA and ISO requirements
\n Develops products in accordance with software lifecycle processes defined in IEC 62304
\n Assists collaborations with external test agencies, design firms and consultants as appropriate to complete assigned projects

\n Health and Safety

Contribute to a safe work environment by complying with all federal & state laws, Northgate policies, procedures and OSHA, if applicable

\n Qualifications, Skills and Working Conditions

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

\n No Relocation Assistance
\n Job Type: Full-timeWork Location: In person/Onsite - Elgin, IL