Manufacturing Process Engineer
About the Role
The primary responsibility of this position is to develop, implement, and sustain highly reliable automated manufacturing processes for the manufacture of medical products. This includes developing user requirements and supporting equipment design, acceptance testing and validation of manufacturing equipment, supporting maintenance in troubleshooting of complex equipment, and monitoring and optimizing equipment performance. Additionally, this role includes the design and development of benchtop manufacturing and testing fixtures and processes, as well as creating drawings and fixturing for prototype / NRE programs.
Other essential functions include:
- Working with automation partners on all aspects of engineering design: mechanical, electrical, safety, PLC/HMI/robotic programming to ensure World Class OEE
- Ensure all manufacturing solutions comply with product design specifications
- Creation and execution of protocols and reports for the qualification and validation of equipment and processes
- Develop technical work instructions for manufacturing use in an ISO 13485 / GMP environment
- Conduct training for equipment operators and maintenance technicians
- Plan and lead continuous improvement activities for existing automated solutions
- Research and development of new, cutting edge automation concepts
- Proactively monitor equipment performance and take action as required to address performance shortcomings
- Create and maintain maintenance documentation, including preventive maintenance procedures and troubleshooting guides
- Identify spare parts requirements
- Design and implement tooling and fixtures
- Define necessary preventive maintenance activities
- Train operators, technicians, and other personnel on the use of equipment and on troubleshooting common equipment problems
- Adhere to quality documents and procedures
- Maintain a safe work environment for employees while performing all duties
About You
- BSME or equivalent technical degree required
- Minimum 3 years of experience supporting advanced manufacturing equipment required
- Experience with developing and executing IQ/OQ/PQ activities, and Test Method and Software Validations strongly preferred
- Medical device manufacturing experience preferred
- Cleanroom experience preferred
- Understanding of PLC controls engineering and ladder logic preferred
- Must possess demonstrated hands-on capability of supporting equipment or robotics in a production environment
- Must be proficient in SOLIDWORKS CAD software use
- Must possess strong analytical and problem-solving skills
- Willing and able to contribute in areas outside of primary responsibility; the company is small and lean, and a wide variety of tasks/projects are required
- Able to operate and thrive in a demanding, fast-paced, fluid environment and work extended hours when required (Picocyl operates on a 10-hour day, 4-day week schedule)
- Able to independently prioritize work and manage multiple tasks
- Clear and effective verbal, written, and interpersonal communication skills
- Must be able to perform physical labor and lift 50 pounds
- Ability to travel domestically and internationally on occasion
About Us
We value your genuine enthusiasm and unique perspective you bring to the company, accordingly we offer competitive pay, discretionary bonus, 401k, healthcare, and a generous paid time off schedule.
Picocyl has an amazing interdisciplinary team of people working at our beautiful location in Golden, Colorado. We need talented individuals to join us and continue driving our story of growth and innovation. At Picocyl you will have the opportunity to deliver value to many of the world’s premier medical device and pharmaceutical companies by building products that are used in medical devices around the world.