Sr Project Engineer

Job Description

Senior Project Engineer – Manufacturing Engineering

Mahwah, NJ

Initial 12 month+ assignment

A leading medical device manufacturer is seeking a Senior Project Engineer to lead capital equipment, automation, and manufacturing improvement projects from concept through production release. This role will have significant ownership of technical execution and will work closely with Manufacturing Engineering, Quality, Operations, Facilities, Supply Chain, and external equipment suppliers.

Job Responsibilities

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• Lead the technical execution of capital equipment, automation, and manufacturing improvement projects from concept through production release.
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• Develop and manage project plans, schedules, action items, technical deliverables, and project documentation.
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• Partner with Project Managers and cross-functional teams to ensure projects remain on schedule, within scope, and aligned with quality and operational requirements.
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• Lead equipment design reviews and work directly with equipment suppliers and subject-matter experts to define and execute technical requirements.
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• Oversee equipment installation, commissioning, FAT/SAT, qualification, validation, and production implementation activities.
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• Serve as a technical lead for equipment and process troubleshooting, driving root-cause analysis and corrective actions.
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• Coordinate technical activities across Manufacturing Engineering, Quality, Facilities, Operations, Supply Chain, and external vendors.
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• Review engineering documentation, equipment specifications, drawings, testing protocols, and validation deliverables.
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• Identify opportunities for process improvements, automation, equipment optimization, and manufacturing efficiency.
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• Provide technical guidance and mentorship to junior engineers and project team members.
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• Ensure projects meet applicable safety, quality, regulatory, and manufacturing standards.
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Qualifications

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• Bachelor’s degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering, or a related engineering discipline.
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• 2–5+ years of relevant engineering experience, preferably within medical device, pharmaceutical, or other regulated manufacturing environments.
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• Demonstrated experience leading or independently executing engineering, capital equipment, automation, or manufacturing improvement projects.
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• Experience working with equipment suppliers, contractors, or external engineering partners.
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• Hands-on experience with equipment installation, commissioning, FAT/SAT, qualification, validation, or production release.
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• Strong troubleshooting, root-cause analysis, and problem-solving skills.
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• Strong project management, organizational, and communication skills.
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• Ability to manage multiple projects and priorities in a fast-paced manufacturing environment.
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• Ability to work effectively with both technical and non-technical stakeholders.
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• Strong technical documentation and presentation skills.
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