Sustaining Manufacturing Engineering Technician IV

Why Orthofix?

Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech.

Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further.

How you'll make a difference?

Summary statement on overall purpose and function of the position.

The Sustaining Manufacturing Engineering Technician IV is responsible for the support and maintenance of the production organization and associated equipment. The Manufacturing Technician will work closely with Production staff, Engineers, and the Supervisor to achieve team performance goals in the areas of Quality, Productivity, and Delivery. They will perform maintenance and management of maintenance procedures, schedules and activities to ensure compliance of the equipment maintenance program to ISO13485 and FDA guidelines.

What will your duties and responsibilities be?

The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.

• Perform routine preventive maintenance on manufacturing equipment to ensure optimal performance and minimize downtime.
• Troubleshoot and repair machinery and equipment as needed to maintain production schedules.
• Plan and schedule preventive maintenance activities, ensuring all equipment is serviced according to manufacturer recommendations and company standards.
• Maintain accurate records of maintenance activities, including work orders, parts used, and equipment status in compliance with ISO13485 and FDA Guidelines.
• Coordinate with external service providers to schedule and oversee specialized maintenance tasks that require expert knowledge or equipment.
• Monitor, order and maintain inventory of spare parts and maintenance supplies.
• Ensure compliance with safety regulations and company policies during all maintenance activities.
• Report all maintenance activities in the CMMS and analyze historical data to observe trends and make recommendations for maintenance optimizations.
• Assist and at times lead the installation of equipment and relocation as needed.
• Assist Manufacturing Engineering with IQ/OQ/PQ on new process equipment, including developing and conducting test protocols and documenting the results.
• Collaborate with Production and Engineering teams to identify and implement improvements to equipment and processes.
• Support the equipment calibration process if needed or when the calibration associate is out of office.
• Provide training and guidance to junior maintenance staff as needed. Build relationships with cross functional teams to achieve collaborative environment.
• Other duties as may be assigned.
  
  
  

What skills and experience will you need?

The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.

Education/Certifications:

• High school diploma or equivalent.
  
  
  

Experience, Skills, Knowledge And/or Abilities:

• Proven experience as a Maintenance Technician in a manufacturing environment. Minimum four to six (4 – 6) years’ experience required.
• Cleanroom manufacturing experience required.
• Strong knowledge of mechanical, electrical, and hydraulic systems.
• Ability to read and interpret technical manuals, blueprints, and schematics.
• Excellent problem-solving skills and attention to detail.
• Strong organizational and time management skills.
• Good safety knowledge & understands and demonstrates safe working practices, lock-out tag-out, safety evaluations and hazards communication for the specific work task.
• Ability to work independently and as part of a team.
• Good communication skills and the ability to coordinate with external service providers.
• Computer literate, ability to use CMMS software in the recording and execution of the maintenance activities, ordering of materials, producing reports for audits & engineering reviews and to provide concise communications to personnel.
• Ability to accurately document and maintain records of maintenance activities, work orders, parts used, and equipment status.
• Must be able to work on problems requiring the exercise of considerable autonomy, judgment, and expertise.
  
  
  

What qualifications are preferred?

The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

Education/Certifications:

• Technical certification or Associate’s degree in a related field preferred.
  
  
  

Additional Experience, Skills, Knowledge And/or Abilities:

• Solid understanding of Lean principles, Continuous Improvements and Toyota Production System.
• A minimum of three (3) years’ experience in the medical device industry.
  
  
  

PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.

Select the appropriate physical requirements below which are essential functions for the position and paste them into the Physical Requirements section of the Job Description.

• This position requires frequent or continuous standing.
• This position requires frequent or continuous bending, stooping, kneeling, or crouching.
• This position requires frequent or continuous walking.
• This position requires frequent or continuous heavy lifting of 40lbs or more.
• This position requires frequent or continuous pushing and/or pulling.
• This position requires frequent or continuous exposure to dust, fumes, gases, odors or other airborne irritants.
  
  
  

DISCLAIMER

The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee’s at-will employment status.

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.

This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.