Chief Plant Engineering Manager

Biomerics; Fairfield, Northern (CA, KY); On-site; USD 140,000 - 190,000; Full time

Job summary

Biomerics is seeking a Plant Manager to lead a 50,000 sq ft medical device manufacturing facility with 105 staff. You will ensure efficient production, uphold quality standards, and manage regulatory compliance across multiple work centers.

You will drive Lean and Six Sigma initiatives, optimize tooling and fixtures, and supervise senior operations leaders while partnering with R&D, Quality, and Regulatory teams.

Qualifications

• Requires a Bachelor’s degree in Mechanical, Industrial, or Electrical Engineering or related field.
• Minimum 4 years of related experience in medical device manufacturing.
• Experience establishing compliant medical device manufacturing procedures and FMEA, V&V, and regulatory alignment.

Responsibilities

• Oversee operations of a 50,000 sq ft plant with ~105 employees.
• Lead process improvements in casting, thermoforming, CNC machining, and 5-axis equipment.
• Drive CAPA, RCM, and Six Sigma initiatives to improve cycle times and costs.

Skills

FMEA

V&V

PLC programming

SCADA/HMI

Machine vision

Robotics integration

Injection molding

CNC machining

Lean operations

CAPA engineering

Education

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Industrial Engineering

Bachelor’s degree in Electrical Engineering

Tools

Allen-Bradley PLC

Siemens PLC

SCADA tools

Job description

Description

Company Overview

Biomerics is a world‑class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next‑generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and patients who depend on our products.

At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team‑oriented, customer‑focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.

As a Plant Manager in the medical devices industry, you play a critical role in ensuring the efficient operation of manufacturing facilities that produce medical devices. Your responsibilities typically include overseeing production processes, maintaining quality standards, ensuring compliance with regulatory requirements, and managing staff. Here’s a more detailed breakdown of what the role involves:

Responsibilities: (50,000 sq ft plant, 105 employees)

Job Summary

Responsible for efficient operation of engineering manufacturing facilities that produce medical devices. Oversee production processes, maintain quality standards, ensure compliance with regulatory requirements and supervise staff. Drive Improvements in Liquid Resin Casting work center by leading the team to design and develop processes, improve tooling, and streamline operations. Manage and improve Thermoforming Work Center through installation, setup and process development of new thermoforming equipment. Lead team to improve cycle times in CNC machining operations with fixture improvements, cutter path improvements, and labor utilization on 3‑axis equipment. Manage projects to install and develop processes for new 5‑axis CNC equipment to drive cycle time, setup, and labor efficiency. Lead root case analysis (RCE), reliability centered maintenance (RCM), and Six Sigma improvement initiatives. Develop fixturing to allow machining that required two setups in 3‑axis to one setup in 5‑axis. Leverage Additive Manufacturing (3D Printing) work center to develop engineered solutions to reduce costs and move products from LRC to 3D Printing. Redesign plant floor layout to improve process flow, eliminating wasted motion and process to reduce cost and improve employee work.

Position supervises 1 Engineering Manager, 1 Facilities Manager, and 1 Production Manager overseeing production processes.

Requirements

Requires a Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Electrical Engineering, or related and 4 years of related experience in medical device manufacturing, which must include some experience in each of the following skills: Establish and maintain compliant medical device manufacturing procedures, including overseeing engineering operations aligned with ISO standards, failure mode and effects analysis (FMEA), hazard identification, and mitigation, and validation and verification (V&V); Direct automation and controls engineering (using PLC programming such as Allen‑Bradley and Siemens, SCADA/HMI systems, machine vision systems, and robotics integration), manufacturing process engineering (using injection molding, CNC machining, cleanroom manufacturing ISO Class 7/8, laser and ultrasonic welding, micro‑assembly & micro fabrication techniques), and statistical and analytical methods; Ensure plant operations compliance and optimizing facilities engineering in regulated environments such as Cleanroom HVAC and environmental control systems, EPA, OSHA, ISO, HEPA filtration, and calibration systems (metrology), equipment reliability engineering and maintenance strategies, and process safety and risk controls for HAZOP, HAZMAT, preventative safety engineering, and EHS compliance; Coordinating CAPA engineering for investigations and corrective and preventative actions and remediations, technical project management for new equipment installation, technology transfers, and process optimization, and cross functional collaboration with R&D, Quality, Regulatory, Validation, Supply Chain, and Automation Teams; Financial planning and control of budgets, designing capital expenditure projects justifications for machinery acquisition and production expansions, profit and loss, absorption, labor, overhead, and expenses, cost analysis control, cost improvement projects, and new products introduction; and Drive operational excellence and continuous improvement by guiding plant floor data standardization, collection, utilization, lean operations, and seamless production execution to maintain quality management systems and regulatory compliance.