Job Title: Operator I - 2nd shift
Department: BU140 & BU145 - Manufacturing
Status: Full Time – Non-Exempt
Reporting To: Production Supervisor
Hours: Monday-Thursday, 4pm-2:30am
Position Purpose:
This position is responsible to provide hands-on medical device coating services on schedule to meet the requirements of customers. This entry-level position must sufficiently complete Harland Medical Systems’ training in work instruction and manufacturing processes and demonstrate increasing capabilities in production.
The Operator I is vital to establishing Harland’s reputation for providing quality products and services according to customer requirements. This person is expected to train under the Supervisor / Lead Operator to learn the technical, manufacturing/assembly, communication, and organizational skills to successfully perform operator job duties with minimal supervision, and eventually no supervision. This person is required to complete work instruction training for at least 40% of coating and inspection processes and show continuous skill development.
This person is responsible to maintain a good attitude and work closely with a team to timely fill work orders by following precise instructions. Basic duties of this job include maintaining coating equipment according to a schedule, prepping work surfaces, reading and executing work instructions, inspecting parts, reporting problems, and maintaining accurate records. It is the job of all operators to follow Good Manufacturing Practice (GMP) and International Organization for Standardization (ISO) guidelines and to ensure work areas are always up to Occupational Safety and Health Administration (OSHA) standards.
The Operator I will be trained to uphold quality standards through inspection. This position is expected to perform quality checks and maintain accurate documentation of procedures performed as required by customer protocols and the established Quality Management System (QMS). The Lead Operator needs to verify 100% of work to ensure the Operator I followed procedures and work order instructions precisely.
To keep production running smoothly, this position is also expected to learn to identify “scrap” as well as possible problems in production. When production issues arise, this position is required to work closely with the Lead Operator and, when necessary, the Production Supervisor to implement quick, effective resolutions. To improve overall productivity, all Harland Operators are encouraged to discuss with their supervisors’ strategies for increasing efficiency, avoiding potential production problems, and reducing scrap.
As a requirement of continued employment, Operators must continue to progress. To become a Operator II, this person must gain at least six months of experience, demonstrate competency in performing all job duties with minimal or no supervision, and undergo training in the process of testing products.
Responsibilities:
- To fulfill Production work plan on time
- To perform coating, inspections, and tests according to work instructions in an effective manner
- Communicates any manufacturing testing issues
- Packaging approved and rejected products according to work instructions.
- Support and/or perform other duties as required
Education, Qualifications & Experience:
- High school diploma or GED required; demonstrated willingness and ability to learn production processes
- Manufacturing or assembly experience preferred (especially in a controlled environment or clean room)
- Team player with positive attitude and excellent verbal and written communication skills
- Detail-oriented professional with the ability to collect and record data and identify and resolve problems
- Demonstrated organization skills with ability to multitask in a fast-paced, high-pressure environment
- Ability to effectively execute work orders according to work order instructions, policies, and procedures
- Computer proficiency using Microsoft Office and ability to learn other software as needed
Working Conditions and Health & Safety:
- ISO Class 7 cleanroom
- Employee is required to use appropriate PPE including, but not limited to, nitrile or latex gloves, lab coat, hair bonnet, shoe covers, beard cover, safety glasses, hearing protection, face shield, or respiratory mask while working in a lab or manufacturing space
Harland Medical System’s commitment to ensure employee health and safety is a priority. Personnel engaged in manufacturing shall obtain training required by ISO 13485, FDA 21 CFR part 820, FDA 21 CFR part 210 & 211, and Harland Medical System’s internal procedures, where deemed appropriate per assigned job functions.
Physical Demands:
While performing the duties of this job, the employee is regularly required to stand and walk on level surfaces for a prolonged period of time. The employee is frequently required to talk and hear; use hands to finger, handle or feel; and reach with hands and arms above shoulder height and below the waist. The employee frequently is required stoop, kneel, crouch or crawl. Using proper lifting techniques, the employee must be able to lift up to 50 lbs. The employee may work on ladders up to 6 feet above the floor. Specific vision abilities required by this job include corrected 20/20 vision, close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. This position may be exposed to areas that require the use of personal protective equipment such as safety glasses with side shields and mandatory hearing protection.
Job Type: Full-time
Pay: $18.00 - $22.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Vision insurance
Education:
- High school or equivalent (Preferred)
Experience:
- Manufacturing: 1 year (Preferred)
- ISO 13485: 1 year (Preferred)
Shift availability:
Ability to Commute:
- Eden Prairie, MN 55344 (Required)
Work Location: In person
