Process Re-engineering / Compliance

Picocyl is a medical device component manufacturer of highly compressed gas cylinders as small as 0.16 mL in volume. Since 2017, Picocyl’s production volumes have continued to grow in both existing volumes and new products, resulting in a need for additional process sustainment team members! The manufacturing environment involves low-mix high-volume continuous production processing, ISO-8 cleanrooms at two Golden, Colorado locations, several automated machines, gas filling, welding, laser etching, and barcode verification systems.

The Process Engineer II is responsible for maintaining, improving, and supporting existing manufacturing processes, equipment, products, and production systems after they have been released to production. This position focuses on improving manufacturing efficiency, reducing costs, increasing product quality, resolving production issues, and ensuring regulatory and quality compliance.

The Process Engineer II serves as a technical resource for manufacturing operations by identifying process improvements, implementing corrective actions, supporting equipment maintenance and validation activities, and collaborating with cross-functional teams to ensure production objectives are achieved.

ADDITIONAL DUTIES & RESPONSIBILITIES Manufacturing Process Support Provide day-to-day engineering support for manufacturing operations.

Monitor existing manufacturing processes to ensure product quality, efficiency, and repeatability.

Investigate manufacturing issues and implement corrective actions to minimize production disruptions.

Analyze process performance data and identify opportunities for continuous improvement.

Develop and implement process improvements to increase throughput, reduce waste, and improve yields.

Support the transfer of new products and processes into routine manufacturing operations.

Establish and maintain process documentation, including work instructions, manufacturing procedures, and engineering specifications.

Equipment & Maintenance Support Support the maintenance, repair, and optimization of manufacturing equipment.

Assist with troubleshooting equipment involving mechanical, electrical, pneumatic, and automated systems.

Coordinate preventive maintenance activities to minimize equipment downtime.

Identify equipment reliability concerns and develop solutions to improve performance.

Recommend and justify equipment modifications, upgrades, and capital improvements.

Support equipment installation, qualification, and validation activities.

Documentation & Validation Prepare and maintain engineering documentation, including protocols, reports, drawings, specifications, and validation documents.

Review and approve engineering change orders and manufacturing documentation.

Maintain accurate records of engineering activities and manufacturing improvements.

Ensure document revisions are completed in accordance with established document control procedures.

Cross-Functional Collaboration Collaborate with Manufacturing, Quality, Supply Chain, Maintenance, and Development teams to resolve production issues.

Provide technical guidance and training to manufacturing personnel.

Participate in design reviews and engineering projects that affect existing manufacturing processes.

Communicate project status, manufacturing concerns, and improvement opportunities to management.

Support supplier qualification and material-related investigations as required.

Quality & Regulatory Compliance Ensure manufacturing processes comply with applicable quality standards and regulatory requirements.

Support investigations related to nonconforming materials, product deviations, customer complaints, and corrective and preventive actions (CAPA).

Participate in root cause analyses using structured problem-solving methodologies.

Support internal and external audits, including customer, regulatory, and certification audits.

Assist in maintaining compliance with applicable standards, including GMP, GDP, ISO 13485, and other quality management requirements.

Ensure compliance with company policies and procedures.

Identify opportunities to improve administrative and purchasing processes.

Education & Experience Requirements Bachelor’s degree in a related engineering field (e.g. Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Materials Science and Engineering, Metallugical Engineering) or a related technical discipline required.

3+ years of manufacturing engineering experience required.

Experience supporting production operations in a regulated manufacturing environment preferred.

Medical device, pharmaceutical, biotechnology, or precision manufacturing experience preferred.

Proficient in AutoCAD and SolidWorks

Proficiency with Microsoft Office applications and enterprise manufacturing systems.

Skills & Abilities Excellent verbal and technical writing skills.

Strong understanding of manufacturing processes and continuous improvement methodologies.

Knowledge of lean manufacturing principles and statistical process control.

Experience with root cause analysis and corrective action methodologies.

Proficiency with Microsoft Office applications and enterprise manufacturing systems.

Ability to manage multiple projects and priorities simultaneously.