Senior Software Engineer

At NTI, we are passionate about innovation and improving minimally invasive surgery. Since 1984, we’ve taken part in advancing laparoscopic surgical techniques by offering a growing portfolio of innovative, reliable, and easy-to-use products and services. NTI received the 2024 and 2023 Edison Award, which honors the best in innovation and the 2023 and 2022 Innovation of the Year Award from the Society of Laparoscopic & Robotic Surgery. Our corporate culture revolves around our five core values: respect, trust, integrity, duty, and innovation, which we live and breathe every day.

Benefits

• Medical, Dental, Vision, and Prescription Coverage
• Paid Time Off
• 401k Retirement Plan with company match
• Short- and Long-Term Disability Insurance
• Life Insurance
• Paid Parental Leave
• Tuition Reimbursement

Responsibilities

• Develop and sustain software-controlled electro-mechanical medical devices for minimally invasive surgery.
• 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.
• Perform both R&D and sustaining engineering activities to launch new products and drive product line extensions and improvements for both OEM customers and NTI-branded product lines.

Design, Development and Testing

• Understand and utilize phase-gated design control process and other control processes throughout the entire product development lifecycle and commercialized product lifecycle.
• Create appropriate software architecture and software specifications to meet high-level product requirements and applicable standards.
• Develop, test, and debug microprocessor-based C and assembly language software based on Software Specifications.
• Collaborate with an interdisciplinary engineering team through the entire product development life cycle, from schematics and breadboards to system prototypes and V&V devices.
• Create test protocols and test reports for software verification and validation for new product launches, design changes, and product line extensions.
• Ensure diagnostic and data acquisition software/equipment are adopted where appropriate to fully characterize software.
• Work closely with internal or customer Marketing departments to develop ideas and concepts for new product offerings addressing unmet user needs.
• Identify and report problems to Staff Engineers or Management while providing direction and support to junior engineers.

Planning, Support, and Collaboration

• Manage assigned projects from start to finish; for major projects, report to Project Manager or Staff Engineers the scheduling and status of major project subsets.
• Assist in cross-department or cross-discipline collaborations to solve complex problems.
• Collaborate with other departments such as Document Control, Manufacturing, and Purchasing in the maintenance of software platforms, software installation procedures, and commercial release of products.
• Assist Sales and Marketing to understand user needs for new products and extensions or improvements to existing products.
• Troubleshoot non-conformances pertaining to the electronics and software portions of products.
• 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.

Regulatory

• Ensure all development guidelines and procedure requirements meet FDA and ISO requirements.
• Develop products in accordance with software lifecycle processes defined in IEC 62304.
• Assist collaborations with external test agencies, design firms, and consultants as appropriate to complete assigned projects.

Health and Safety

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

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 the 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 of cybersecurity best practices.
• Strong software troubleshooting skills and proficiency with debugger applications.
• Assist in the digital transformation of the 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.).

Job Type: Full-time
Work Location: In person/Onsite - Elgin, IL