Process Engineer

JOB SUMMARY:
The Process Engineer supports maintenance and continuous improvement activities within the surgical blade’s operation, focusing on optimizing machine output, reducing waste, and ensuring operational efficiency. This role also emphasizes the development of technical skills among area setup operators and mechanics. Must have a strong understanding of machine design and setup, with proven hands-on and analytical troubleshooting skills for complex mechanical systems. The role requires the ability to diagnose, resolve, and optimize mechanical issues efficiently, demonstrating both practical experience with machinery and critical problem-solving abilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Help build and maintain systems that support manufacturing operations and production cells, including data collection, preventive maintenance, machine rebuilding, and spare parts management.
2. Coordinate the organization and management of technical drawings for production machinery.
3. Mentor setups operators and mechanics in proper machine setup, maintenance, rebuilding, and troubleshooting.
4. Drive machine improvements to enhance longevity, increase uptime, and reduce scrap.
5. Serve as a liaison with the in-house machine shop to improve spare parts turnaround, support drawing revisions, and enhance service speed and quality.
6. Ensure compliance with QSR, ISO 13485:2003, Canadian MDR, PAL, and other applicable regulations.
7. Identify sources for spare parts and coordinate with central stores to ensure appropriate inventory levels are maintained.
8. Support the creation and maintenance of task documentation, including SOPs and work instructions for production machinery.
9. Lead validation activities for new machinery and other equipment within the scope of responsibility, ensuring performance, quality, and regulatory compliance.
10. Assist in the development, integration, and implementation of advanced manufacturing technologies, including servo controllers, PLC systems, and industrial PCs, to improve production efficiency and automation.
11. Assure that employees under supervision, when applicable, adhere to all company policies, procedures, and standards.
12. Other duties assigned by Immediate Leader.

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Bachelors in engineering science; preferred Mechanical or Electrical.
• At least one to three (1-3) years of experience in high-tech manufacturing setting (Medical Device or Pharmaceutical, or Electronic) with experience in Manufacturing Engineering and Design Engineering.
• Experienced in the use of statistical tools and data driven decision-making, knowledge of Six Sigma Tools and methodology a plus.
• Proven history of cost improvement project implementation
• Good troubleshooting experience, including ladder logic, pneumatic & electrical machine controls, & mechanical alignment.
• Basic AutoCAD or SolidWorks experience. Microsoft Word & Excel basic skills. Minitab, Visio, Project, & PowerPoint skills a plus.
• Experienced in the development and execution of machine / equipment validations.
• Proficient in English and Spanish (written and oral).

At Aspen Surgical, we strive to build a diverse work force through equal opportunity employment that embraces and leverages the differences that each individual has to offer. This job description is only a summary of the typical functions of the job and not intended to be an exhaustive list of all job responsibilities, tasks, and duties. Aspen Surgical Products, Inc. is an equal opportunity Employer F/M/Disability/Vet/Sexual Orientation/Gender Identity.