Metals Operator - Erie, CO

2. Operator I

Runs equipment and part handling steps with set programs and parameters. Focus is on following the work instruction exactly, handling parts carefully, keeping accurate records, and entering parts correctly into an ERP system

3. Operator II

Runs any process in level I as well as shape setting for laser-cut stents. This process takes more technical skills, including fixture and mandrel setup, checking furnace or sand bath settings, and catching small dimensional or visual defects. A mistake here can scrap a full lot, so a higher level of detail and precision is expected. Trains Operator I on qualified steps.

4. Operator III

Can run any process in level I or II. Operator III mainly runs the most technical processes in the area. Laser welding needs precise setup and skill welding on very small joints. Chemical processes require safe chemical handling, tight control of time, temperature, current and bath concentration, where small changes affect material removal, surface finish and part performance. Requires the highest level of detail, precision, documentation accuracy and safe chemical handling. Owns chemical bath records and trains others on Operator III steps

Essential Duties and Responsibilities:

1.       Production Operations

Run metals process steps to approved work instructions to meet quality standards and requirements and hit production goals. Move between process steps based on Kanban signals and lead direction to keep WIP moving and Kanbans filled. Run only the steps for your level, and only after sign-off in the training matrix.

2.       Quality and In-Process Checks

Do the in-process checks called out in the work instruction. Stop and escalate when parts or the process are out of spec, and report nonconformances and equipment problems right away to the supervisor, or engineering.

3.       Documentation and Traceability

Complete documentation accurately and in real time following Good Documentation Practices, including logs, equipment and bath records, and IQMS transactions. Keep lot and part traceability, and keep product segregated, identified and protected from damage and contamination.

4.       Chemical Processing (Operator III)

Prepare, check and maintain de-ox and electropolish baths, including verifying concentration, temperature and bath life, and logging results. Handle, transfer and dispose of acids and other hazardous chemicals per SDS, safety procedures and hazardous waste rules.

5.       Safety and House Keeping 

Follow all safety rules, wear required PPE and report safety issues right away. Keep work areas clean and organized using 5S.

6.       Training

Complete required training and keep training records current. Help train other operators on steps you are qualified on.

7.       Engineering Support and Continuous Improvement

Support engineering with process trials, validation runs (IQ/OQ/PQ) and work instruction updates. Bring forward ideas to improve safety, quality, delivery and cost.

Qualifications:

Required:

• High school diploma or GED
• 2+ years of manufacturing experience in a regulated industry (Medical device, aerospace, semiconductor, pharmaceutical or similar)
• Hands-on experience following written procedures and completing production documentation.
• Basic math and measurement skills, including use of callipers, scales, timers and thermometers.  
• Basic computer skills.
• Able to read, write, and speak English proficiently.  

Highly Preferred:

·         Chemical processing experience such as chemical etching, electropolishing, passivation, plating, anodizing or pickling (required for external hires at Operator III).

·         Experience with nitinol or other medical implant metals (stainless steel, cobalt chrome, titanium)

·         Experience with laser cutting, and laser welding

·         Experience working under ISO 13485 and FDA 21 CFR 820 (QMSR)

·         Cleanroom or controlled environment experience

·         ERP system experience

·         Associates degree or technical certificate in a manufacturing, chemistry or related field

Skills and Work Environment:

Key skills:

• Strong attention to detail and the discipline to follow procedures exactly, every time.
• Good hand-eye coordination and fine motor skills for handling small, delicate parts, including work under a microscope.
• Willing to stop the line and speak up when something looks wrong.
• Able to learn several processes and switch between them during a shift.
• Works well on a team and communicates clearly across shifts.

Physical Requirements:

·         Stand and walk for most of the shift

·         Lift and carry up to 50 pounds

·         Close vision work, including extended use of microscopes and magnification

·         Wear required PPE for long periods of time. This may require a full face respirator and fit test.

Work Environment:

• Manufacturing floor setting with chemical process areas containing concentrated acids and other hazardous chemicals. This setting may have higher noise levels and varying temperatures.

Position Type & Expected Hours of Work:

• 1^st Shift Monday to Friday, 7:00 AM to 3:30 PM. Additional hours or overtime may be required to meet project deadlines or address urgent issues.