This position is for Goodwill's new manufacturing facility location at 38th and Sheridan in Indianapolis, IN. 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.

Preferred Competencies

• Resourceful Innovator - Takes initiative in growing knowledge in the production process in order to streamline efficiencies.
• Test Run - Performs tests on products in order to assess reliability and suitability.
• Knowledge of Quality Standards - Understands applicable national and international requirements, specifications, and guidelines to ensure that products and processes are of good quality and fit for purpose.

Other Requirements

• 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 Comprehensive health plan Paid time off (PTO) and paid holidays
• Life, dental and vision insurance
• Nationally recognized preventive health and wellness program Section 125 pretax health spending account, dependent care spending account, and premiums

Company Overview

Since 1930, Goodwill of Central & Southern Indiana has helped Hoosiers become more economically self-sufficient through employment, education, job training, and health services. Today, we are one of the largest Goodwills in North America, providing services to thousands of individuals and families each year. We find that we are at our best when we work together, as One Goodwill, across the organization, delivering vital services and resources, and empowering Hoosiers to increase their independence and reach their full potential. We will continue to change lives daily through the development and execution of initiatives that enrich the lives of those we serve through education, health, and employment. Everything we accomplish will be through the lens of equity as we work towards equitable outcomes for those who are facing systemic barriers that lock them in the vicious generational cycle of poverty.

As a government contractor, Goodwill is subject to Executive Order 11246, the Rehabilitation Act of 1973 (Section 503), and the Vietnam Era Veterans Readjustment Act of 1974 (VEVRAA), all as amended, which require government contractors to ensure nondiscrimination in employment and to take affirmative action to employ and advance in employment qualified persons without regard to sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected veteran status, or any other characteristic protected by applicable law. As a government contractor, we are required to report certain data regarding our applicants and employees to the government. In accordance with these requirements, we invite you to voluntarily disclose your sex, race, national origin, disability, and protected veteran status by completing the forms on https://www.goodwillindy.org/careers/

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• No weekends

Ability to commute/relocate:

• Indianapolis, IN 46226: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Have you ever been convicted of a crime (misdemeanor or felony) that has not been expunged or sealed by the court? If yes, please provide details:

Experience:

• Manufacturing: 1 year (Required)

Work Location: One location

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