Manufacturing Engineering Manager - Direct Hire

Prestige Staffing Services is seeking an experienced Manufacturing Engineering Manager for a Direct Hire opportunity in Fort Wayne, Indiana.

Position Summary

• Manage, lead, develop, and maintain product engineering functions and systems that meet regulatory requirements.

Position Responsibilities

• Initiate plans, facilitate their execution, and communicate product engineering and operational initiatives to support plant and corporate synergies and goals.
• Serve as an engineering and manufacturing representative providing support and guidance for new product development, intercompany sourcing synergies, and outsourced value-added services through volume production internally and at customer locations.
• Responsible for engaging multi-functional departments to ensure the project progresses fluidly in all aspects, including manufacturing ramp schedules, capital equipment specification and acquisition, validations and adherence to quality specifications, and process design iterations.
• Interfaces with internal stakeholders, customers, and suppliers as necessary.
• Relies on extensive experience and judgment to plan and accomplish goals.
• Technically support customer for design for manufacturability (DFM).
• Ensure customer product specifications and ISO/FDA procedures are met or exceeded.
• Aggregate costs of product from estimating and provide margin projections through full production release.
• Aggregate DMR (Device Master Records) to customer and company specifications.
• Act as project “Owner” over the interdepartmental activities of Quality, Operations, Materials and Engineering toward successful execution of project goals.
• Makes critical decisions that impact profitability, service level, and quality in alignment with corporate goals.
• Participate in Audits (FDA, Customer and Internal) to provide representation of our quality system.
• Coordinate and chair process development closure meetings.
• Support Existing Product as required:
• Provide Backup for other quality functions:

Requirements

• Five or more years working in the field of quality regulated manufacturing.
• Five or more years Supervisory/Managerial experience in a regulated manufacturing environment.
• Bachelor of Science in technical field or equivalent demonstrated experience in a regulated manufacturing environment.
• Thoroughly understand ISO 13485 requirements.
• Must have experience with MS Office software. Experience in Epicor is preferred.