Manufacturing Engineer - Medical Device (Avon)

Job Title: Manufacturing Engineer II

Company: Intellectt Inc.

Location: Avon, IN

Job Description

We are seeking a Manufacturing Engineer II to support manufacturing processes, equipment qualification, quality systems, engineering documentation, and continuous improvement initiatives within a regulated medical device manufacturing environment.

Job Responsibilities

• Develop and execute technical activities to improve existing products, manufacturing processes, and equipment.
• Manage Quality Management System (QMS) documentation and ensure compliance with applicable company procedures and quality requirements.
• Author and manage engineering change orders, including work instruction updates and document revisions using Windchill.
• Lead installation qualifications and develop and execute installation qualification protocols.
• Own equipment and process documentation, including equipment qualification and non-product software validation.
• Support temperature mapping, validation activities, and maintenance of qualification records.
• Provide manufacturing floor and operations support, troubleshoot equipment and process issues, and coordinate corrective actions.
• Support robotics, production printers, and other manufacturing equipment.
• Coordinate maintenance, calibration, and preventive maintenance activities.
• Manage incoming material setup, repack setup, packaging setup, and master data maintenance.
• Prepare technical reports, presentations, and monthly business review metrics.
• Coordinate with vendors and cross-functional teams on engineering, manufacturing, quality, and project activities.
• Maintain accurate documentation and ensure compliance with applicable quality systems and business procedures.
• Apply engineering principles and problem-solving techniques to improve manufacturing performance and process reliability.

Required Qualifications

• Bachelor's degree in Science or Engineering, preferably Electrical, Software, Mechanical, or a related engineering discipline.
• 3–5 years of relevant engineering experience.
• Experience managing Quality Management Systems (QMS).
• Experience authoring engineering change orders and preparing technical documentation.
• Experience leading installation qualifications and developing installation protocols.
• Strong technical writing, analytical, troubleshooting, and problem-solving skills.
• Ability to coordinate cross-functional projects and manage multiple priorities.
• Strong communication and documentation skills.

Preferred Qualifications

• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with Windchill change management and work instructions.
• Experience with equipment and process qualification, non-product software validation, and temperature mapping.
• Familiarity with manufacturing operations, equipment maintenance, calibration, and preventive maintenance.
• Experience in medical device manufacturing or another regulated manufacturing environment.

Pay Scale : Approximately $40-42/Hr on w2 (Negotiable based on the experience)

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.