US - Manufacturing Engineer-Sr jobs in United States
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The Fountain Group · 2 months ago

US - Manufacturing Engineer-Sr

The Fountain Group is seeking an experienced Senior Manufacturing Engineer to lead and support site and manufacturing transfer projects in a regulated environment. This role offers the opportunity to drive technical excellence and ensure seamless product transfers and validations.

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Responsibilities

Lead and execute manufacturing/site transfer projects end-to-end
Oversee process validation (IQ/OQ/PQ), change control, and documentation
Collaborate cross-functionally with Quality, Regulatory, and Supply Chain teams
Solve complex technical challenges and support continuous improvement

Qualification

Medical device manufacturingManufacturing transfersProcess validationLean ManufacturingSix SigmaERP systemsPLM systemsMES systemsCommunicationProblem-solvingOrganizational skills

Required

Bachelor's degree in Engineering, Science, or related field
4+ years of experience in medical device manufacturing or other regulated industries
Proven experience with manufacturing or site transfers and/or new product launches
Strong knowledge of process validation and manufacturing documentation
Excellent communication, problem-solving, and organizational skills
Ability to work independently with minimal supervision
Must be US Persons or Green Card Holder due to export compliance

Preferred

Experience with orthopedic implants, instruments, or precision assembly
Knowledge of Lean Manufacturing and Six Sigma
Proficiency in ERP, PLM, or MES systems

Company

The Fountain Group

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The Fountain Group is a staffing firm that specializes in rendering contingent workforce solutions to various industries.

Funding

Current Stage
Late Stage

Leadership Team

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Jahnavi Patel
Finance Business Partner
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Company data provided by crunchbase