Overview

The Software Engineer (including software and hardware design) will provide vital input to the development of new and the maintenance of existing Tactile Systems medical products. Responsible for definition, development and realization of medical devices through firmware and electrical hardware system specification and creation. This position will provide detailed design documentation that includes product risk assessments, design for manufacturing, verification planning, testing and reporting. Works with suppliers and assists in efforts to improve processes and automate inline testing as part of ongoing continuous manufacturing and quality improvement initiatives.

Responsibilities

• Collaborate cross-functionally to assist with developing new products, implementing product improvements, and managing product design changes
• Design, develop, document and release device software and electrical hardware designs
• Create, prototype, and debug device software and electrical design per Tactile Systems phase documentation
• Develop and maintain engineering documentation (requirements, specifications, manuals, bills of materials, etc.) and ensure quality, completeness, accuracy and timeliness support quality, production and supply chain requirements
• Ensure that the software development system and processes comply with ISO 62304
• Prepare and execute verification and validation protocols for products, equipment, and processes to assure that acceptance criteria are defined, and verification and validation activities are appropriately completed
• Participate in product risk assessments via Hazard Analysis and design & process FMEA procedures
• Participate in the evaluation, selection, testing and documentation of electrical components
• Direct and assist designers at contracted companies and affiliated organizations
• Keep current with new technologies
• Ensure that projects and assigned tasks are completed on time and on budget
• Develop, maintain and improve test procedures, documentation, work instructions, tools and fixtures
• Other duties as assigned

Qualifications

Education & Experience

Required:

• Bachelor or master’s degree in Software Engineering, Computer Science, Electrical Engineering or related field with proven equivalent experience
• Design and development experience with C/C for embedded 8-, 16- & 32-bit micro-controllers
• Experience in design/manufacture of medical devices (preferred), or other highly regulated industry
• Experience with revision control systems such as Git
• Development and debugging experience with in-circuit emulators, JTAG debuggers, oscilloscopes, logic analyzers and protocol analyzers
• Experience with embedded driver implementations: USART, ADC, SPI, RS-232, I2C, CAN, Ethernet
• Working knowledge of script-based languages such as Python

Preferred:

• C# and GUI development in application frameworks such as .NET
• Familiarity with ISO 62304, ISO 13485, IEC 60601-1 and FDA Design Controls
• Experience in Design for Manufacturing, DFMEA, PFMEA, DOE, and Validations
• Familiarity with wireless communication methods such as BLE
• Design experience with Real Time Operating Systems 

Knowledge & Skills

• Working knowledge of MS Office software applications (Word, Excel, Project, Visio, etc.)
• Strong written/verbal communication and presentation skills to clearly articulate concepts
• Ability to work cross-functionally to solve technical problems
• Demonstrated ability to meet project deadlines
• Ability to make timely decisions based on stakeholder input and engineering fundamentals
• Organization and prioritization skills – adaptable to changing business needs and adept at juggling numerous
• Demonstrated problem solving skills and analytical abilities
• Ability to hold effective and productive meetings
• A passion for continuous learning
• Ability to collaborate with both technical and non-technical team members

Competencies

• Functional/Technical Skills
• Innovation
• Action Oriented
• Customer Focused
• Listening
• Teamwork
• Communication
• Process Oriented
• Priority Setting
• Problem Solving