Operations Manager - Miami Lakes

FloodGate Medical•Tampa, FL

3d•Onsite

About The Position

This is an Operations Manager opportunity leading the ops team at BIOREP Technologies, a boutique medical device CDMO headquartered in Miami Lakes, FL, specializing in the contract development and manufacturing of complex cardiovascular and electromechanical devices for early and growth-stage MedTech companies. BIOREP operates in a fully regulated, ISO 13485-certified environment with Class 10,000 cleanroom manufacturing capabilities and a team of roughly 25 deeply experienced engineers and scientists. They function as a true development partner — embedding themselves in client programs from design through production — and are increasingly acting as an incubator and accelerator for innovative device technologies. With new partnerships and product programs actively coming online, this is an established company at a genuine growth inflection point and a compelling time to join. In this role you'll own the day-to-day manufacturing operation — from cleanroom management and production scheduling to supply chain coordination and vendor oversight — while leading a small team and driving on-time delivery across two business units. You'll also play a key role in an upcoming ERP transition as the company scales. If you thrive in a lean, regulated environment and want real ownership over how an operation runs and grows, this one's worth a conversation.

Requirements

Bachelor Degree in Industrial, Mechanical or Manufacturing Engineering, Operations/Supply Chain management or equivalent
5+ years as Manufacturing or Operations Manager or equivalent position
Experience with FDA and ISO 13485 Manufacturing Environment
Experience supporting or operating within ISO-classified cleanrooms (ISO 8 or below) in a regulated environment
Experience with Implementing ERP System
Manufacturing & Equipment Processes
Excellent communication and people skills
In depth knowledge of diverse business functions and principles (e.g. supply chain, , production planning, etc.)
Working knowledge of data analysis and performance/operation metrics
Strong Process Improvement and Analytical Skills
Experience with MS Office (Word, PowerPoint, Excel)

Nice To Haves

Lean Six Sigma Green belt or higher

Responsibilities

Manages day to day operation and maintenance of the Class 10,000 cleanroom
Own daily production scheduling, resource allocation, and execution
Develop and manage production plans based on demand and capacity
Map and improve manufacturing processes; implement SOPs and workflows
Lead ERP Manufacturing implementation including requirements, testing, adoption and development of associated procedures
Oversee equipment utilization and coordinate maintenance
Partner cross-functionally with Quality, Engineering, and Operations
Manage relationships/supplier agreements with external partners/vendors
Maintain and manage department budget
Directs and monitors department employees to accomplish goals of the manufacturing plan, consistent with established manufacturing and safety procedures.
Acts as liaison between department management/subordinate levels, as well as executive/department manager levels to inform personnel of communications, decisions, policies and all matters that affect their performance, attitudes and results.
Hires, trains, develops and evaluates staff. Takes corrective action as necessary on a timely basis and in accordance with company policy.
Ensures compliance with current federal, state and local regulations (i.e. ISO, FDA, OSHA).
Consults with Quality and Regulatory Affairs Department as appropriate.
Establishes and monitors production and product costing.
Identifies, recommends and implements changes to improve productivity and reduce cost and scrap, monitor scrap and rework data.
Directs the establishment, implementation and maintenance of production standards.
Support various programs essential to manufacturing procedures (e.g., training, safety, housekeeping, cost reduction, worker involvement, security, etc.).
Support major projects (e.g., plant layout changes, installation of capital equipment, major repairs, etc.).
Perform miscellaneous duties and projects as assigned and required.
Lead continuous improvement initiatives (Lean/Six Sigma)