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Scientific. Clinical. Software Engineering

Sr. Project Engineer

Orange County Metro Area, CA

Job Type: Engineering Job Number: JN -112020-27616 Region: Orange County Metro Area

Job Description

Sr. Project Engineer

Biotech Industry

Irvine, CA


Supporting the MS&T Technical Transfer engineering team with R&D projects transferring new products, enhancements and acquisitions into production; while ensuring compliance to our policies and procedures.


Plans and coordinates assigned project work as lead or in support of the assigned lead project manager(s)/engineer(s). Independent decision making, professionalism, project management skills and technical engineering experience is required.


Interacts with manufacturing, HSE, facilities, quality and design engineering groups in design, scale-up and hand-off of technology transfers to commercial manufacturing along with facilitating, documenting, and providing equipment and process development qualification and support.

Supports the preparation of all manufacturing and support documentation (SOP s, PM s, Spare Parts Lists).

Demonstrates working knowledge of manufacturing equipment and processes, IQ/OQ/PQ and process verifications and calibration.

Demonstrates working knowledge of setting up and transferring pilot and production lines.

Performs assignments independently with minimal guidance as to the general results expected, often times dealing with complex problems.

Provides direction and regular contact to other engineers, vendors and contractors assigned to the project.

Ensures effective communication and coordination on assigned projects between all parties.

Plans, schedules, and coordinates: engineering, qualification, and validation activities for projects.

Analyze, prepare, and/or review reports, studies, specifications, drawings, test plans, and other data to execute work.

Ensures product, components, processes and procedures are reviewed and include DFM input.

Achieve quality, schedule and budget targets on assigned projects.

Keep site management informed of all circumstances that could affect projects.


Skills:


Project management or engineering experience developing pilot and production lines and processes is required.


Creative problem solving and trouble shooting skills.

Competent computer skills and use with MS Office, Project, PowerPoint, Word and Excel is required. ProE or Solidworks experience is also preferred.

Ability to interact effectively with all levels of employees and management

Good organizational, administrative, and time-management skills

Self-motivated and able to remain productive with little supervision oversight

Must be a team player with excellent interpersonal skills.

Excellent communication skills, both written and oral are required.

Must be able to demonstrate influencing and persuasion skills with an ability to drive decisions in project teams.


Education:


A minimum of a Bachelor s degree in an engineering discipline is required. Equivalent experience may be accepted.

A minimum of 5 years Medical device industry work experience in ISO-13485 regulated environment is required.

Must have 5 years of successful experience managing high visibility and complex projects.

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