Project Engineer

Job Description

We are seeking a driven and detail-oriented Project Engineer to support capital projects and continuous improvement initiatives within a medical device manufacturing environment. This role will be responsible for leading cross-functional projects, ensuring compliance, and delivering results on time and within budget.

Key Responsibilities:

-Lead and manage engineering projects from concept through execution and closure

-Develop project plans, timelines, budgets, and resource allocation

-Coordinate cross-functional teams including Manufacturing, Quality, Validation, and Regulatory

-Ensure compliance with FDA regulations, GMP, and ISO 13485 standards

-Oversee equipment installation, upgrades, and process improvements

-Support and execute validation activities (IQ/OQ/PQ)

-Identify risks and implement mitigation strategies

-Drive continuous improvement using Lean principles

-Prepare and present project status reports to stakeholders

Qualifications:

-Bachelor’s degree in Engineering (Mechanical, Electrical, Industrial, or related)

-3–5+ years of experience in medical device or pharmaceutical manufacturing

-Strong knowledge of project management methodologies

-Experience with validation, change control, and regulated environments

-Familiarity with FDA (21 CFR Part 820) and ISO 13485

-Proficiency in project management tools (MS Project, Excel, etc.)

Key Skills:

-Strong leadership and organizational skills

-Excellent communication and stakeholder management

-Problem-solving and analytical thinking

-Ability to manage multiple projects simultaneously

Equal Opportunity Employer / Disabled / Protected Veterans

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For temporary assignments lasting 13 weeks or longer, the Company is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.

We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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Company Description

This company offers growth and a great group of people to work with.

Full-time