Senior Software Project Manager
Why Join ACIST?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the ACIST team has the power to make a difference......every day!
This is a leadership role responsible for working with cross-functional teams globally to ensure all dependencies/deliverables are available in a timely manner to provide smooth software development execution. Coordinate and manage the design, development, and testing of software embedded in diagnostic and interventional cardiology devices. Participate in all phases of the software lifecycle, including concept development, requirements, design, implementation, and testing. This position does require some hands-on activity with the tools and processes used in development of application software and embedded firmware applications. The Project Manager will also function as the overall project lead for software and is responsible for creating, monitoring, and tracking high-level schedules.
Coordinate development activities between multiple project teams (domestic and overseas):
- Manage local software development related activities and coordinate with remote teams to achieve project goals
- Serve in the role of a Scrum Master responsible for planning and executing sprint plans with the support of functional leaders
- Effectively interface cross-functionally with other product development groups and departments throughout the project lifecycle
- Ensure proper software design practices are used to develop medical devices to meet specific performance requirements and deliver on goals according to the product development quality system. These activities include developing requirements specifications, design, implementation and testing of software and embedded software algorithms or/and general Windows applications and GUIs.
- As a team member, engage in the completion of various project activities, from definition, identifying software functional requirements, implementation, code reviews, and final release according to medical device development processes.
- Work closely with cross-function teams, including design reviews with QA, RA, test engineers,
hardware engineers to ensure the product design meets the requirements, including safety, reliability, and serviceability. Be creative and innovative in the product development process.
- Make, recommend, and justify critical technical decisions in product design. Decisions should be based on broad investigation and testing.
Qualifications (Knowledge, Skills & Abilities):
- B.S. or M.S (Preferred) in discipline such as Software Engineering, Computer Engineering, Computer Science, Computer Systems Engineering
- 5+ years of software engineering design
- 3+ years of new product development
- 2-3 years providing technical leadership and mentorship
- Extensive experience practicing formal Agile methods in product development
- Understanding and practice with Continuous Integration/Continuous Delivery tools
- Windows software application development: C#/C++/WPF
- Experience evaluating and mitigating risks in software application development
- Extensive experience and appreciation for software testing methods and planning
- Excellent verbal, written, and interpersonal skills
- Experience developing software within a regulated industry (IEC 62304 / Medical industry preferred)
- Development/Process Tools: MS Visual Studio, Jira, Git, Jama
- Target operating systems: Windows 10/IoT
- GUI development experience: WPF, UWP
- 3-5 years working in product development within a medical device company
- Background/Understanding of Cybersecurity and practical project work to identify, mitigate, and test for Cybersecurity threats
- Understanding and practical application of ISO14971 and TIR57 and Risk Management in the context of Medical Device Software
- Understanding and practical application of TIR45 – Agile Practices in Medical Device Software Development
- Experience with distributed embedded systems
- Other programming languages such as .NET, XML, XSL, HTML, Python and communication protocols (TCP/IP, UPnP, Web Services, SOAP, CAN)