Medical Device Software Manager
Kforce Inc

Scottsdale, Arizona

This job has expired.


RESPONSIBILITIES:

Kforce's client is a growing company that is seeking a Software Engineering Manager that has experience in the Medical Device Industry. This position is in Scottsdale, AZ. We are working directly with the Hiring Manager on this exclusive search assignment.Summary:You will be responsible to coordinate activities of his team for the design, documentation, code construction, testing and maintenance of software applications for medical Device products. This is a hands-on position; You will be trusted with full and unrestricted access to our products, code and documentation. With the full support of the engineering team, you will be expected to learn these products and obtain a detailed understand of its software functions. From this understanding, ensure the functional requirements are documented. You may also be required to coordinate performance of non-software tasks to support company objectives such as feasibility studies, V&V activities, and QMS compliance. You will interact internally with the other departments and overseas with their sister company's R&D software team.Essential Functions:
  • Design products to IEC62304, IEC60601, IEC13485 and IEC14971standards
  • Generate and review software engineering documentation (SRS, SAD, SDD and STP)
  • Develop technical solutions to achieve Marketing/Sales/QARA requirements
  • Mentor Software Engineers and promote an open and creative work environment
  • Coordinate software development activities with European sister company


REQUIREMENTS:

  • A Bachelor of Science from an accredited institution is required; MS degree is a plus but not required
  • 3-5+ years of software development management or Lead experience in medical device companies
  • Knowledge and understand of FDA CFR 21
  • Ability to work independently or in highly collaborative environments
  • Excellent Critical Thinking and -Outside the Box- problem-solving skills within the context of a regulated environment
  • Strong Project Management skills
  • Strong experience with C++
  • Coaching, mentoring and evaluating performance of team members
  • Ability to document processes and articulate complex technical concepts and solutions
  • Work within a regulated environment
  • Ability to travel occasionally to Europe to interface on projects
  • Experience with Medical Imaging products is a plus, but not required
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.


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