Principal Software Engineer - Merz North America, Inc

Completes Software Engineering work for R&D Product Development group.

Essential Duties and Responsibilities

• Manage software engineering projects in context of providing system operational capabilities from concept to full production based upon accurate project schedule and budgets.

• Train, mentor and supervise other junior engineers and technicians.  Work with other Engineers in planning, prioritizing and executing assigned tasks within deadlines.

• Coordinate engineering efforts provided by outside design partners and resources ensuring accurate designs meet customer requirements.

• Oversee the technical aspects of projects, providing software standards and guidance for engineering teams to follow.
• Assess product conformance to specifications by developing requirements, designs, implementations, code reviews, tests, adjusting, meeting performance standards, maintaining quality standards.
• Develop System Software Architecture for the medical device based on stakeholder needs.
• Responsible for software engineering product development from prototype through verification. Work with QA team in preparing test cases, plans and procedures. Review and evaluate software contribution to product operation and life cycle artifacts using informal and formal reviews with internal and external cross functional stakeholders.
• Present and develop new product concepts, components; providing feasibility studies to show alignment with customer requirements assist product development if/when concept(s) mature and evolve.
• Design and analyze integrated software implementations and associated life cycle artifacts; sustain existing R&D products per Standard Operating Procedures (SOP).
• Sustain the software development environment and equipment on which the software is developed and tested.  This includes the integration of tools, whether off-the-shelf or developed in house.  This includes the development or evolution of software tools that increase efficiency while meeting SOP.
• Responsible for developing software documentation, IFU, risk assessment and mitigation as well as product requirements trace analysis required for FDA and regulatory affairs.
• Recommend new technologies to ensure quality and productivity.
• Perform other duties as assigned based on business needs.

Knowledge, Skills and Abilities

• Experience with medical device. Medical devices standards like IEC62304,  ISO14971, IEC60601 - Required
• Knowledge on B-Mode Ultrasound is plus - Preferred
• Proficient with software architecture methods and development tools used with C++, C, HTML: Microsoft Visual Studio - Required
• Proficient with Windows 10 Operating System and Advanced PowerShell - Required
• Knowledge on FDA cybersecurity requirements - Required
• Profiling/Optimizing software - Required
• Proficient with Jira, Bitbucket and DevOps strategies - Required
• Software test and release strategies and execution of controlled software - Required
• Proficient with MasterControl - Preferred

• Experience integrating real-time systems on a Windows Host.  Design experience with real-time systems operating on Windows - Required

• Experience designing, reviewing and running unit tests - Required
• Proven record of coordinating technical resource to meet project schedules - Required

Knowledge of Methods

• Experience with engineering analysis tools and the complex system engineering development and test environment - Required
• Experience implementing designs including real-time communication with connected equipment - Required
• Proficient in digital systems development, system operations, requirements, modelling, implementation, configuration management, testing, tracing and the associated artifacts that support industry standards via SOP. - Required
• Analytical skills to understand how to develop software based on the end user's needs - Required

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Research and Development