Software Project Engineer-Medical Device

  • Full-time

Company Description

KMC Systems, a wholly-owned subsidiary of and co-located with Elbit Systems of America, is a leading contract designer and manufacturer of medical devices and instrumentation for OEM’s in the areas of diagnostic, therapeutic, and biomedical products. With more than 30 years of experience, KMC is an ISO 13485 certified and FDA registered firm with expertise in all aspects of medical product development, verification, design for and transition to production. Additional capabilities include flexible turnkey manufacturing, depot repair and full compliance with FDA QSR regulations and GMP practices.

Job Description

Project Planning and Management - Assist in define project scope and schedule while focusing on regular and timely delivery of value; organize and lead project status and working meetings; prepare and distribute progress reports; manage risks and issues; correct deviations from plans; and perform delivery planning for assigned projects.

Team Management - Assist in team development while holding teams accountable for their commitments, removing roadblocks to their work; leveraging organizational resources to improve capacity for project work; and mentoring and developing team members.

Product Owner Support - Support the Product Owner in managing customer expectations for project deliverables, managing stakeholder communications, and helping to implement an effective system of project governance.

Process Management and Improvement - Define and manage a well-defined project management process and champion ongoing process improvement initiatives to implement best practices for Agile Project Management. Thorough understanding of SW tracking metrics and the proven ability to employ the appropriate metrics to provide accurate progress assessments with minimal impact on team performance.

Team Building - Promote empowerment of the team, ensure that each team member is fully engaged in the project and making a meaningful contribution, and encourage a sustainable pace with high-levels of quality for the team.

Qualifications

  • Solid understanding of software development life cycle models as well as expert knowledge of both Agile and traditional waterfall project management principles and practices and the ability to blend them together in the right proportions to fit a project and business environment
  • Engineering degree with software development experience preferred.  Proven track record maybe substituted for BS/BA
  • A proven track record of successfully implementing software development projects using Agile methodologies including 8+ years of experience as a Project Manager managing large, complex projects in a high-tech development environment with multi-function teams. Medical Device in an ISO experience in an IEC 62304 / ISO14971 / 13485 environment preferred.
  • Prior experience with SCRUM/Agile methodologies with enterprise-level application development projects. PMI-ACP, CSM, or equivalent preferred.
  • Experienced with multi-function project teams with at least 10-15 team members including Developers, Business Analysts, and SQE/SWQA Personnel
  • Sufficient level of technical background to provide highly-credible leadership to development teams and to be able to accurately and objectively evaluate complex project risks and issues
  • Ability to provide leadership and to collaborate with customers and develop strategies and solutions of high business value

SKILLS REQUIRED:

  • Very effective interpersonal skills including mentoring, coaching, collaborating, and team building
  • Strong analytical, planning, and organizational skills with an ability to manage competing demands
  • Ability to establish/maintain high level of customer trust and confidence
  • Proven ability to partner with technical lead on software development projects and ensure objectives, goals, and commitments are met
  • Solid understanding of and demonstrated experience in using appropriate tools:
    • Agile Project Management tools such as Jira/Greenhopper, Rally, VersionOne or equivalent
    • Microsoft Project, Visio, and all Office Tools
  • Excellent oral and written communications skills and experience interacting with both business and IT individuals at all levels including the executive level
  • Creative approach to problem-solving with the ability to focus on details
  • Knowledge of Agile techniques (e.g., User Stories, TDD, Continuous Integration, Automated Testing, etc.)
  • Knowledge of Agile methodologies (e.g., Scrum, Kanban) and alternatives [TL]
  • Proven experience with identification and introduction of new tools and technologies to support Agile process within an existing software development organization
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