Senior Supply Chain Manager - Michigan

FloodGate Medical•Tampa, FL

7d•Onsite

About The Position

The Senior Supply Chain Project Manager/Director leads supplier selection, qualification, and manufacturing transfer projects for SteriCUBE — identifying and developing strategic manufacturing partners, transferring products and processes to external suppliers, and ensuring projects are executed on time, within budget, and in compliance with medical device quality and regulatory requirements. This is a hands-on role for a supply chain professional with strong experience in medical device manufacturing, supplier management, contract manufacturing, new product introduction, and manufacturing transfers. The role works cross-functionally with Engineering, Quality, Regulatory, Operations, and senior leadership while serving as the primary project leader for supplier and transfer initiatives.

Requirements

Bachelor’s degree in Supply Chain Management, Operations, Engineering, Business, or a related field
7+ years of progressive experience in supply chain, sourcing, manufacturing operations, or supplier management
Demonstrated experience leading supplier selection and manufacturing-transfer projects within medical device or another highly regulated manufacturing industry
Strong background in contract manufacturing and external supplier management, including supplier qualification, RFQs, negotiations, cost analysis, and performance management
Proven ability to manage multiple complex projects simultaneously
Strong understanding of manufacturing processes, quality systems, engineering documentation, and production controls
Excellent analytical, organizational, communication, and negotiation skills, with the ability to communicate effectively with both technical and executive audiences
Comfort working in gray areas and determining next steps to create clarity
Willingness to travel periodically to supplier and manufacturing sites

Nice To Haves

ISO 13485 and FDA-regulated medical device manufacturing experience
Design transfer, process validation, PPAP/FAI, or similar manufacturing qualification experience
Experience managing contract manufacturers and critical component suppliers
PMP certification; lean manufacturing, Six Sigma, or continuous improvement background
Experience developing dual-source strategies and supporting new product introduction (NPI)

Responsibilities

Lead identification, evaluation, selection, and onboarding of new suppliers and contract manufacturers for scoped projects
Conduct supplier assessments, capability reviews, and due diligence; lead RFQs, negotiations, commercial evaluations, and supplier recommendations
Establish and maintain strategic relationships with contract manufacturing partners
Identify and mitigate supply chain risks, including single-source dependencies and capacity constraints
Lead manufacturing transfer projects from design or existing suppliers to new or alternate partners, developing detailed plans, schedules, milestones, and resource requirements
Coordinate transfer of drawings, specifications, BOMs, work instructions, inspection methods, tooling, fixtures, and test methods
Partner with Engineering and Quality to ensure processes are adequately defined, validated, and controlled before production release
Manage deliverables supporting pilot builds, first articles, process development, process validation, and production ramp-up
Ensure transfers are executed in accordance with company change-control and quality-system requirements; identify risks and develop mitigation plans
Serve as primary project manager for supplier selection and manufacturing-transfer initiatives, coordinating across Supply Chain, Quality, Regulatory, Finance, and external suppliers
Establish clear project ownership, timelines, and accountability alongside supplier counterparts
Lead project meetings and communicate status, risks, decisions, and action items to stakeholders and leadership; escalate issues and drive timely resolution
Maintain accurate project documentation and ensure commitments are tracked through completion
Partner with Quality and Regulatory to ensure suppliers meet applicable medical device requirements
Lead supplier qualification, quality agreements, supplier audits, and supplier corrective actions
Ensure supplier and transfer activities comply with FDA, ISO 13485, and company quality-system requirements, with documentation completed before production release
Oversee investigations and root-cause analysis for supplier or manufacturing issues arising from NPD pilot or transfer projects