Manufacturing Engineer - Medical Device
Intellectt Inc · Avon, Indiana, United States
FULL TIMEpermanent
Job Description
Job Title: Manufacturing Engineer IICompany: Intellectt Inc.Location: Avon, IN
Like the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete job description.
Job DescriptionWe 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 ResponsibilitiesDevelop 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 QualificationsBachelor'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 QualificationsLean 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)BenefitsEmployees 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. xzbcwsv Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.
Like the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete job description.
Job DescriptionWe 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 ResponsibilitiesDevelop 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 QualificationsBachelor'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 QualificationsLean 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)BenefitsEmployees 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. xzbcwsv Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.
Details
| Company | Intellectt Inc |
| Location | Avon, Indiana, United States |
| Type | FULL TIME |
| Niche | tech |
| Experience | permanent |