Job Description

| Operations Manager — BIOREP Technologies

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.

Minimum Requirements

EDUCATION

• Bachelor Degree in Industrial, Mechanical or Manufacturing Engineering, Operations/Supply
  Chain management or equivalent

EXPERIENCE

• 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)
• Lean Six Sigma Green belt or higher (Preferred)

Job Requirements

• 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)

Compensation Information

• Base salary: Depends on experience
• Bonus potential, annual based on KPIs and company profit
• 401(k)
• Healthcare
• HSA
• Vision & Dental
• Paid Time Off

Location

• Territory Parameters: Miami Lakes, FL (HQ Location); On-site - flexible hours