Business Analyst / Product Owner at Horizontal Talent in Mounds View, Minnesota

Job Description:

POSITION DESCRIPTION

• The Company's Cardiac Ablation Solutions team is looking for a Senior Software Systems Engineer to join our SW/FW R&D Organization to design and develop new software-based features and modifications to capital systems for the cardiac electrophysiology lab.




• Areas of responsibilities may include requirement generation and review, application and test tool design, Agile product ownership or scrum master roles, test design, and software documentation. Candidates must be able to translate design inputs into software options, concepts, and user stories, write detailed software requirement specifications, and generate and review design documentation, interface specifications, test specifications and test reports in compliance with design control procedures used within the medical device industry.




• Cardiac Ablation Solutions seeks candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action.

POSITION RESPONSIBILITIES

• Assist in leading software projects in an Agile environment as part of multi-site team. May serve in Scrum master and/or Product Owner roles for various workstreams, depending on project needs and team size.




• Support the team in working efficiently and effectively; according to clear priorities, schedule, and goals; and delivers quality designs according to process.




• Coordinate, write, proof, and finalize technical project documents as needed with limited supervision.




• Design, test, and document software components and computing systems software to be integrated with mechanical and electrical systems.




• Train on and apply the appropriate standards, processes, procedures, and tools throughout the software development life cycle, following FDA regulations as well as IEC 62304 for medical device software.




• Establish strong relationships with cross-functional engineering team members and be able to prioritize SW development and testing tasks for developers, considering cross-functional dependencies and goals.




• Anticipate and mitigate risk points. Suggest and support decision-making tradeoffs between schedule, budget, and scope, while meeting safety and regulatory requirements.




• Develop a broad understanding of the company's  Cardiac Ablation Solutions product lines.




• Maintain an attitude of positive flexibility, sometimes performing assigned work outside the boundaries of a typical software systems engineering job description to meet overall team deadlines and milestones.

MUST HAVE: MINIMUM QUALIFICATIONS

• A Bachelors Degree in engineering field with 5 years of relevant experience, or advanced degree with 3 years of relevant experience. Software, Computer Science, Electrical, or Biomedical Engineering preferred.

NICE TO HAVE:

• Masters Degree in Engineering, Computer Science, or Business Administration (MBA).




• Strong verbal and written communication skills.




• Experience with highly regulated and/or safety-critical systems is required; experience working in the medical device industry and understanding of regulations such as 21CFR Part 820 and ISO 13485, and ISO 62304 preferred.




• Strong knowledge of software engineering tools and process: project tracking/scheduling, document management, static analysis, unit testing, requirements verification, issue/bug tracking, configuration management, integration/release testing, etc.




• Solid understanding of structured product development: requirements-driven engineering, requirements documentation, rigorous verification, Failure Mode and Effects Analysis (FMEA), etc.




• Experience with Microsoft suite of tools (Project, Word, Excel, PowerPoint, etc.)




• Experience with Agile Software Development Methodologies (Scrum, Kanban, SAFe).




• Certification for Agile roles such as Scrum Master, Product Owner, Scrum Developer, etc.




• Experience in ideation, development, and release of large electro-mechanical capital products with both embedded firmware and application software running on a Windows desktop.




• Experience as a SW development engineer with growing knowledge/experience in a lead project role. Understanding of broad technical software design concepts such as object-oriented programming, common design patterns, and software testing.




• Experience with common software development tools/platforms/languages (GIT, Azure DevOps/TFS, C#/.NET, WPF, C++, Embedded C++, etc).




• Proven ability to work in a team environment with strong collaboration skills, engaging with technical and non-technical staff across multiple geographical R&D sites, including significant remote/videoconference-based work.

PHYSICAL JOB REQUIREMENTS

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.




• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.




• While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.




• The employee is also required to interact with a computer, and communicate with peers and co-workers




• May need to sit at a computer terminal for extended periods of time




• Employee must occasionally lift and move up to 30 lbs.




• Limited (?10%) travel required if based in Mounds View, MN.




• Up to 25% regular travel if based in Independence, OH office.




• Employee may need to work on-site with test setups and equipment in-office up to approximately 50% of time. 2 or more days/week expected for on-site collaborative or equipment-dependent work in a long-term hybrid model.