Manufacturing Engineer - Medical Device

Job Description

Job Title: Manufacturing Engineer II

\n

Company: Intellectt Inc.

\n

Location: Avon, IN

\n

\n

Job Description

\n

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.

\n

\n

Job Responsibilities

\n

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

\n

\n

Required Qualifications

\n

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

\n

\n

Preferred Qualifications

\n

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

\n

\n

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

\n

Benefits

\n

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

\n

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.

\n

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

\n

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