Intermediate​/Senior Development Manufacturing Engineer nufacturing Engineer

As a custom designer and manufacturer of pressurized gas cylinders and delivery system solutions, Picocyl stands apart in the global market through its unique business model and core technical competencies. The company specializes in developing solutions for the medical industry and other sectors with stringent quality and critical mission requirements, manufacturing these solutions within its ISO 13485 certified Class 8 cleanroom facilities using proprietary processes.

Through a full lifecycle approach that combines design and engineering services, rapid product development, state-of-the-art manufacturing capabilities, and a commitment to unsurpassed quality, performance, and efficacy, Picocyl has earned a reputation as one of the medical industry’s premier innovators and thought leaders in delivery system technologies.

Picocyl’s flagship Pico-Cylinders have become an industry standard for single-use pressurized gas cylinders. Engineered specifically to meet the rigorous demands of medical applications and quality compliance requirements, Pico-Cylinders are designed to be leak-free while delivering superior performance, high energy and power density, and low operational noise. Manufactured in cleanroom facilities in Golden, Colorado, Pico-Cylinders are available in multiple standard form factors and can also be fully customized to meet unique size, weight, fill volume, pressure, puncture force, and gas type requirements.

• Manage manufacturing engineering projects:
  Lead all aspects of projects related to onboarding new product lines, implementing new manufacturing equipment, and optimizing existing production processes. Manage relationships with automation vendors, develop project plans, maintain schedules, and communicate technical and financial progress to leadership.
• Develop and implement automation solutions:
  Own the technical execution of large‑scale automation projects. Analyze customer and product requirements, design components as needed, and generate assembly processes and automation URS documentation. Collaborate with automation vendors on equipment design and integration. Conduct equipment acceptance testing to ensure conformance with specifications. Develop, release, and maintain production work instructions and supporting processes for new equipment implementations.
• Validate automation systems and processes:
  Apply medical device and automation expertise to develop efficient and robust validation strategies for automated manufacturing processes. Author and execute validation protocols and reports while ensuring timely review and release through the Picocyl quality and document control systems.
• Mentor and support engineering teams:
  Provide technical guidance and mentorship to fellow engineers by sharing manufacturing engineering knowledge and best practices. Assist team members with problem analysis, troubleshooting, and implementation of effective solutions while supporting execution of project objectives.
• Support production operations:
  Provide hands‑on support to manufacturing operations, particularly for newly transferred product lines and specialized processes. Respond to production issues with urgency, troubleshoot equipment and process concerns, and implement corrective actions as needed. Ensure all activities are properly documented within the Picocyl Quality System through NCRs, Deviations, Engineering Analysis Reports, and Change Orders.

• Bachelor’s degree in a related engineering discipline such as Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Manufacturing Engineering, or Materials Science and Engineering
• 7+ years of engineering experience within a fast‑paced and demanding manufacturing environment
• Experience working within the medical device industry and operating under an ISO 13485‑compliant Quality Management System
• Demonstrated success managing large‑scale engineering and manufacturing projects
• Ability and willingness to mentor, guide, and support other engineers and cross‑functional team members
• Strong technical writing and documentation skills
• Design experience including assembly fixtures, inspection fixtures, tooling, and product components
• Hands‑on experience with automated assembly equipment, automation integration, and manufacturing operations
• Experience performing manufacturing time studies, cost analysis, and process optimization activities
• Knowledge of Lean Manufacturing and Six Sigma concepts and methodologies
• Demonstrated competence in core manufacturing engineering disciplines, including:
• Structured problem solving
• Root cause investigation and analysis
• Development and implementation of effective corrective actions
• Mechanical and process design activities
• Real‑time production floor support and troubleshooting
• Hands‑on training and support of production operators