Job Description
Job DescriptionDescription:
We are seeking a skilled and motivated Equipment & Facilities Engineer to support and improve production operations in a regulated medical device manufacturing environment. This role is responsible for maintaining and enhancing equipment performance, ensuring facility readiness and compliance, and driving continuous improvement in alignment with FDA, ISO 13485, and cGMP standards.
Job Duties/Responsibilities
- Manufacturing Equipment Support:
- Manage preventive and corrective maintenance programs for critical manufacturing equipment and infrastructure.
- Partner with Quality and Regulatory teams to ensure compliance with validation protocols and risk assessments.
- Troubleshoot mechanical, electrical, pneumatic, and automated systems to minimize downtime.
- Document changes and maintain equipment-related records per internal quality systems.
- Facilities Engineering:
- Oversee maintenance and operation of facility infrastructure including cleanrooms, HVAC, water systems, and critical utilities.
- Support cleanroom compliance, including ISO Class 7/8 areas.
- Support facility expansions, layout changes, and utility upgrades to accommodate production growth.
- Ensure EHS and OSHA compliance for facility operations and equipment installations.
- Manage external contractors and vendors for facility and equipment projects.
- Assist in root cause analysis and resolution of equipment-related nonconformances and deviations.
- Support audits and inspections by providing facility and equipment documentation and technical expertise.
- Monitor and analyze equipment performance data to identify trends and drive continuous improvement.
- Ensure compliance with applicable building codes, safety regulations, and environmental standards.
- Coordinate with external contractors and vendors for facility and equipment projects.
- Comply with Company policies and procedures.
- Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions.
- Other duties as assigned.
Requirements:
Required Qualifications:
- Bachelor’s Degree in Mechanical Engineering or related field or combination of education and experience totaling 8 years.
- Hands-on experience with electromechanical equipment, automation systems, and utilities used in production environments.
- Ability to train team members in preventative maintenance and calibration of equipment.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Excellent written and verbal communication skills.
- Strong analytical and project management skills with the ability to manage multiple priorities.
- Proficient in using Microsoft office programs (Outlook, Word, Excel, and PowerPoint).
- Willingness to work a flexible schedule.
- Able to travel for work as needed.
- Satisfactorily pass comprehensive background screening.
- Satisfactorily pass drug screening (if applicable to position).
Preferred Qualifications:
- Experience supporting Class I, II, or III medical devices.
- Six Sigma or Lean Manufacturing certification.
- Knowledge of PLC systems.
- Familiarity with root cause analysis (e.g., 5 Whys, Fishbone, FMEA).
- Experience working with and around radioactive materials
- Experience supporting a functioning class 7 cleanroom
Physical Demands/Working Conditions:
- On-site role in a manufacturing environment.
- May require entry into controlled environments (ISO Class 7/8 cleanrooms).
- Occasional off-hours work to support facility or equipment projects.
- Frequent exposure to hazardous materials requiring appropriate PPE and precautions when working with hazardous materials and chemicals.
- Requires frequent finite hand/eye coordination.
- Frequently picks up, carries, and moves items up to 50 lbs.
- Some evening and weekend work depending upon workload.
- Some overnight travel may be required for work, events, and trainings.