Project Specialist

Description

100% onsite, 8am – 5pm

Interview process: initial phone screen, then onsite panel interview

Is there a likelihood of an extension past the initial duration: yes

Requirements:

• Must have medical device experience.
• Previous project analyst or project coord experience supporting program managers in the past
• Strong communication, must be able to communicate with upper leadership
• Able to work independently

Background Experience:

• Scientific or engineering experience would be preferred

Client is seeking a Project Specialist responsible for supporting and assisting product/project teams.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities and the below-mentioned responsibilities as reasonably required by business needs.

• Supports a more senior project manager on programs with a broad multidisciplinary and or technical scope.
• Assists in maintaining master schedules, resources, and project budget.
• Assists in tracking, managing, and facilitating the resolution of project risks and issues.
• Processes and maintains design control documentation and Design History Files, per procedures.
• Maintains design control documentation supporting design inputs, risk, and other trace matrix data.
• Drafts core team-specific design control documents (e.g., project plans, traces) for team review.
• Coordinates design reviews, deliverables, and reviews information. Ensures action items are resolved and documented.
• Interacts with team members, including senior-level staff, in driving the completion of deliverables.
• Communicates status of project deliverables to core team leader, team members, and stakeholders.
• Other duties as assigned.
• Liaison with QA Auditors for audit of DHF, as needed.

Qualifications

Education:

• BS Degree in Science or Engineering
• Project Management coursework or certification desirable (e.g., CAPM, PMP)

Experience:

• 2 - 5 years of experience in a regulated industry, ideally supporting project teams
• Familiarity with Design Controls and Regulatory Requirements

Skills

• Knowledge of some aspects of project management (timelines, budget, financials)
• Proficient with the use of project management tools (e.g., MS Project, Smartsheet, JIRA, Asana, Planview) to manage projects
• Excellent organization skills, and attention to detail
• Ability to interact effectively with personnel from top to bottom of the organization with diverse cultural and educational backgrounds.
• Good communication and problem-solving ability.