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Description

1. Troubleshoot manufacturing equipment to ensure production continuity and document failure analysis and corrective actions per quality management system and GMP requirements.
2. Communicate to production staff in a timely manner about equipment status and repairs progress.
3. Diagnose, and debug complex optical/electro/mechanical equipment, computer systems, coupled with software solutions.
4. Direct meetings with cross-functional teams to discuss technical issues in detail, create consensus on path forward and until issues resolved.
5. Identify systemic performance issue, design, and implement effective and sustained mitigations and repairs to enhance overall productivity. Problems could have multiple causes without existing standard procedures to troubleshoot.
6. Author equipment troubleshooting procedures and create postmortem reports to document troubleshooting activities, technical findings, and repairs.
7. Lead the hands-on training to other engineers and technicians to improve knowledge and response times.
8. Drive equipment initiatives to improve product quality, increase part throughout, decrease equipment downtime, and strengthen safety measures.
9. Lead the cross functional team to identify the new equipment specifications to scale up production capability, upgrade current equipment and introduce new technology.
10. Manage internal and/or external equipment builder and spearhead equipment deployment to production line.
11. Optimize manufacturing equipment during validation and qualification (IQ/OQ/PQ)
12. Produce Verification/Validation protocols (IQ/OQ/PQ) and related technical reports to support the transfer of new products, processes, and equipment into production.
13. Lead failure investigations and root cause analyses as they relate to equipment performance.
14. Oversee the Calibrations and Preventive Maintenance (PM) requirement (procedures and schedule) for all manufacturing equipment, including performing the critical PM activities.
15. Manage critical spare parts inventory to ensure business continuity.
16. Comply to GMP and GDP guidelines and QMS documentation requirement.
17. Other duties or support assigned by the manager.

1. Bachelor of Science in mechanical, manufacturing or biomedical engineering with 7 years of relevant experience or equivalent combination of education and experience to perform at this level.
2. Minimum 3 years of working in a regulated environment (GMP, ISO or FDA)

1. Proficient with equipment troubleshooting, repairs, validations, and calibration and PM in a regulated environment
2. Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment and ambiguous scope.
3. Strong project management, oral and written communication, and interpersonal skills.
4. Proficient with electro-mechanical troubleshooting, pneumatics, system/SW integration, PLC, or vision system
5. Must be able to read and understand mechanical/pneumatic drawings and electrical schematics.
6. Experience with 3D design packages (Solidworks, Inventor, Pro E)
7. Experience with creating BOMs, product specifications, and engineering drawings interpretation (GD&T)
8. Ability to work under pressure and stringent timelines to recover equipment down situations.
9. Proven ability to quickly diagnose problems through analysis of inspection reports, system log files, system parametric diagnostic data and other test results, and provide clear and comprehensive solutions.
10. Hands on experience with high volume and fast pace medical device manufacturing equipment.
11. Extensive experience with semi-automated equipment troubleshooting, root cause analysis, equipment engineering, failure investigations and automated assembly equipment.
12. Proven experience with mechanical design concepts, machinery and automation: Electrical, Mechanical, and Electromechanical schematics, motors, pumps, vacuum, and hydraulics.
13. Prior experience with ink jet printers, or micro volume dispense technology would be a plus

• A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
• Company-Provided Life and Accidental Death Insurance
• Short and Long-Term Disability Insurance
• Retirement Plan including a generous non-discretionary employer contribution and employer match.
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Commuter Benefits
• Various voluntary benefit offerings
• Discount programs
• Parental leaves

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).