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Senior Manufacturing Equipment Engineer
2 months ago
Position Overview
The Senior Manufacturing Equipment Engineer will oversee the maintenance and operational efficiency of production machinery to ensure a safe work environment while achieving productivity and quality objectives. This role involves collaboration with diverse teams to enhance the performance and capabilities of manufacturing equipment.
Key Responsibilities
- Diagnose and resolve issues with manufacturing equipment to maintain production flow, documenting failure analyses and corrective measures in accordance with quality management and regulatory standards.
- Provide timely updates to production personnel regarding equipment status and repair progress.
- Analyze and troubleshoot complex optical, electro-mechanical systems, and software integrations.
- Facilitate discussions with cross-functional teams to address technical challenges, fostering consensus on solutions until issues are resolved.
- Identify and rectify systemic performance challenges, implementing effective and sustainable solutions to boost overall productivity.
- Develop and document troubleshooting protocols and post-incident reports detailing technical findings and repairs.
- Conduct hands-on training for engineers and technicians to enhance knowledge and response capabilities.
- Drive initiatives aimed at improving product quality, increasing throughput, minimizing equipment downtime, and reinforcing safety protocols.
- Lead cross-functional teams in defining new equipment specifications to enhance production capacity and integrate new technologies.
- Oversee equipment builders and manage the deployment of machinery to production lines.
- Optimize manufacturing equipment during validation and qualification processes.
- Create verification and validation protocols and related technical documentation to support the introduction of new products and processes into production.
- Lead investigations into equipment failures and conduct root cause analyses.
- Manage calibration and preventive maintenance schedules for all manufacturing equipment, ensuring compliance with established procedures.
- Maintain an inventory of critical spare parts to support operational continuity.
- Adhere to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) as well as quality management system documentation requirements.
- Perform additional duties as assigned by management.
Qualifications
- Bachelor's degree in Mechanical, Manufacturing, or Biomedical Engineering with at least 7 years of relevant experience, or an equivalent combination of education and experience.
- A minimum of 3 years of experience in a regulated environment (GMP, ISO, or FDA).
Skills and Experience
- Expertise in troubleshooting, repairing, validating, and maintaining equipment in a regulated setting.
- Ability to thrive in a fast-paced environment, demonstrating flexibility and adaptability to changing circumstances.
- Strong project management, communication, and interpersonal skills.
- Proficient in electro-mechanical troubleshooting, pneumatics, system/software integration, PLCs, or vision systems.
- Capability to interpret mechanical and pneumatic diagrams and electrical schematics.
- Experience with 3D design software (e.g., Solidworks, Inventor, Pro E).
- Familiarity with creating Bill of Materials (BOMs), product specifications, and interpreting engineering drawings (GD&T).
- Ability to work effectively under pressure and meet stringent deadlines.
- Proven skills in diagnosing issues through analysis of inspection reports, system logs, and diagnostic data, providing clear and actionable solutions.
- Hands-on experience with high-volume medical device manufacturing equipment.
- Extensive background in troubleshooting semi-automated equipment, conducting root cause analyses, and managing automated assembly systems.
- Solid understanding of mechanical design principles, machinery, and automation, including electrical, mechanical, and electromechanical systems.
- Prior experience with inkjet printers or micro-volume dispensing technologies is advantageous.
Compensation and Benefits
The estimated salary range for this position is between $122,400 and $152,400, with eligibility for a variable annual bonus based on performance metrics. BioFire Diagnostics offers a comprehensive Total Rewards package, which may include medical, dental, and vision plans, life insurance, disability coverage, retirement plans, wellness programs, and various voluntary benefits.