Medical Device Operator- 38th & Sheridan Location

This position is for Goodwill's new manufacturing facility location at 38th and Sheridan in Indianapolis, IN. These are full-time shifts Monday-Friday during daytime hours.

The Goodwill Commercial Services facility is registered as a medical device manufacturer with the FDA. The products manufactured here include components of introducers, sheaths, drainage catheters, and needles.

The Medical Device Operator I position assembles, inspects and packages medical devices according to written specifications and manufacturing instructions.

Example Duties and Activities 

• Follows written instructions to hand assemble and inspect a variety of medical devices.

• Boxes, packages, and labels complete sets and products in the processing flow.

• Sets up, maintains, and operates machinery. 

• Handles tools such as razor blades, hole punchers, and table top grinders and may use a microscope or magnification during the inspection and assembly process.

• Uses test equipment for product inspection such as calipers, pin gauges, meter stick, meter scales, micrometer.

• Maintains accurate and complete documentation reporting any quality problems or findings.

• Works at different workstations following prescribed safety and quality requirements. 

• Adheres to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and/or other applicable regulatory requirements.

Required Competencies 

• Degree and Credential Requirements - NONE! We value candidates who can demonstrate capability and articulate how prior experiences will help them contribute.  We believe in continuous learning and professional development.

• Reading Technical Documentation – Reads, interprets, and follows technical documentation outlining specifications and manufacturing instructions to assemble, inspect, and package products

• Manual Dexterity - Makes coordinated hand and finger movements to grasp and manipulate objects and handles tools to complete quality work.

• Detail Oriented - Inspects assembled products with thoroughness and accuracy to identify quality problems or non-conformances to specifications.

• Deductive Reasoning - Thinks plausibly and makes sound judgments when following written instructions adhering to applicable regulatory and safety requirements.

• Operational Adaptability & Precision - Sets up and maintains machinery adjusting the controls quickly and repeatedly to exact positions while remaining calm and receptive in fast-paced situations.

Other Requirements

• Ability to read and comprehend detailed instructions is required

• Hard to Very Hard Physical Work - Is able to spend time in excess of 8 hours sitting, standing, walking, stooping, kneeling, and crouching. Uses hands to grasp, carry, feel, or touch both products and machinery. Has the ability to move and lift 50+ pounds. Can manage frequent exposure to moderate/loud noise.

• Visual Acuity - Meets the screening requirements of 20/40 vision using both eyes with or without correction.

• Minimum of 18 years of age

Benefits: Full-time employees may participate in a comprehensive benefits program that includes:

• Continuing education and leadership development as well as tuition reimbursement

• Comprehensive health plan, dental and vision insurance

• Paid time off (PTO) and paid holidays

• Company provided life insurance

• Nationally recognized preventive health and wellness program

• Section 125 pretax health spending account, dependent care spending account and premiums

• Retirement options with partial company match %

• Employee discount (Goodwill retail and additional external services)

• Mental health services with up to 15 free counseling sessions for you and any family members

• Free nurse health coaching services on site