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.
ConsultingRecruitingStaffing Agency
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
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
The Fountain Group is a staffing firm that specializes in rendering contingent workforce solutions to various industries.
Funding
Current Stage
Late StageRecent News
Kelly Services, Inc.
2025-05-17
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