Engineering Project Manager

Company: Apex Systems ( Learn More )

General Information
US-MA-Framingham Massachusetts
4 Year Degree
Not Specified
Not Specified
Job Description

Seeking a Project Manager with 5+ years’ experience in medical devices. To be considered for this role, candidates must possess a proven track record of managing project in a matrix organization, experienced in design controls and quality systems, systems engineering and system and embedded software V&V methods. Preferred experience includes PMP certification, class II and III medical devices, knowledge of FDA and EU regulatory requirements, etc. For immediate consideration, please send your updated resume to [Click Here to Email Your Resumé]

Must Haves:

  • Proven track record of successfully managing projects in a matrix organization
  • Experienced in design controls and quality system of Medical Devices (Class II or III)
  • Experienced in system engineering and system and embedded software V&V methods

  • V&V engineering is responsible for verification and validation of complex firmware / embedded software application and hardware products within the company.
  • This project manager oversees and manages the operational aspects of ongoing V&V activities and serves as liaison between project management and planning, project team, and line management.
  • He/she ensures that products are verified and validated in adherence to the applicable regulatory requirements for medical devices and best practices on schedule and within budget.

  • Responsibilities include the following and other duties may be assigned
  • Represent V&V on project core teams regarding project requirements, scope, schedule, budgets, implementation planning and product support
  • Review and approve system level requirements and creates test strategies that increase test coverage, validate scalability and improves quality
  • Ensure clear ownership and commitments for resources and timelines for all V&V tasks
  • Work with line managers to develop project plans and work and schedule estimates
  • Develop mechanisms for monitoring project progress and for intervention and problem solving with project managers and line managers
  • Update project core teams and management on the issues and progresses.
  • Escalate blocking issues and drive to resolution
  • Conduct and encourage frequent formal and informal communication within the team to ensure full engagement and efficient operation
  • Evaluate alternative development options to reduce time to market and minimize commercial and technical risk
  • Work with System, V&V and other Engineering functions to uncover V&V gaps and determine and execute challenge tests
  • Contribute to the growth and development of the V&V staff, in close partnership with line manager

  • Demonstrate strong and clear accountability for operational and project success
  • Solid organizational skills including attention to detail and multi-tasking skills
  • Demonstrate leadership, strong problem-solving ability and action orientation when facing uncertainty
  • Possesses the skills, knowledge and aptitude to engage, influence, and direct all functions involved in the development of the assigned product
  • Experienced with the principles of system and embedded software V&V methods
  • Experienced in design controls and quality system of Medical Devices (Class II or III)
  • Experienced with hardware and software lifecycle processes and associated standards and regulations
  • Knowledge of FDA and EU regulatory requirements for medical devices (ISO13485, 60601-1, 60068 and 62304)
  • Experience with requirements management, configuration management, issue tracking tools, etc.
  • Proficient in project management tools such as MS Project, Excel and Visio PMP is preferred
  • Education:

  • BS or MS degree in Biomedical, Electrical, Computer Engineering and Physical Sciences
  • Experience:

  • Five to Seven years of Medical Device development experience with BS degree or four years of experience with MS degree

  • Job Requirements