• 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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required:

• 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.

• Requirements:

o Must have medical device experience.

o Previous project analyst or project coord experience supporting program managers in the past

o Strong communication, must be able to communicate with upper leadership

o Able to work independently

• Background Experience:

o Scientific or engineering experience would be preferred

Manpower San Diego

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