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Manufacturing Engineer

Collabera

Manufacturing Engineer IIPay Range: $35/hr to 40/hrLocation: Minnetonka, MN 55343Work Type: OnsiteContract Duration: 03 to 06 months with possible extensionJob Summary:The Manufacturing Engineer II will provide technical leadership and engineering support within a regulated medical device manufacturing environment.The role will focus on manufacturing process development, process validation, risk assessment, process controls, and continuous improvement initiatives.The engineer will take ownership of complex technical assignments and develop effective solutions where established precedents may not exist.The position requires strong collaboration with internal teams, external stakeholders, suppliers, and engineering partners.The successful candidate will manage multiple projects while ensuring technical activities, timelines, and deliverables remain aligned with business objectives and quality requirements.Key Responsibilities:Lead complex manufacturing engineering activities and provide technical direction for assigned projects.Support manufacturing processes through process validation, process controls, risk assessment, and continuous improvement activities.Develop and implement effective engineering solutions for manufacturing challenges while considering impacts across related systems and processes.Plan and manage project timelines, deliverables, technical activities, and cross functional dependencies.Collaborate with internal stakeholders, external partners, suppliers, quality teams, and engineering groups to resolve technical and operational issues.Support supplier changes and assess their impact on manufacturing processes, validation activities, and product quality.Participate in peer reviews and provide technical input for verification and validation activities.Identify potential manufacturing risks and recommend appropriate corrective and preventive actions.Required Qualifications:Bachelor of Science or Bachelor of Engineering degree in Mechanical Engineering, Electrical Engineering, Software Engineering, or a related engineering discipline.Minimum 5 to 6 years of Manufacturing Engineering experience within a Class III medical device environment.Strong experience with process validation including IQ, OQ, and PQ.Experience with manufacturing risk assessment and process controls.Demonstrated experience working with internal and external stakeholders.Experience managing project timelines and supporting multiple projects simultaneously.Experience working with cross functional teams and managing supplier changes.Preferred Qualifications:Experience supporting complex medical device manufacturing operations.Experience implementing new manufacturing methods and approaches.Experience with verification and validation activities within a regulated manufacturing environment.Experience driving continuous improvement initiatives.Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable

Vacancy posted 5 days ago
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