Facilities Engineer I job vacancy in Xtant Medical Holdings Inc – Jobs in Montana

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Job Details
Company Name : Xtant Medical Holdings Inc
Company Location : Belgrade, MT 59714
Job Position : Facilities Engineer I
Job Category : Jobs in Montana

Job Description :

Status: Full Time, Exempt
Reports To: Director of Facilities, Engineering

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A. Purpose and Scope of Position*
The Facilities Engineer will take responsibility for the facility maintenance provisions, ensure that day-to-day tasks are undertaken and coordinate with specialist system vendors.
They will oversee the planning and scheduling of resources required to deliver the Facilities maintenance service including parts, labor, and the input of the specialist service delivery partners. Once tasks are completed the Facilities Engineer will audit all services to ensure that workmanship is of the highest standards.
They will have input into the development of the maintenance procedures and protocols including method statements, permits to work and appropriate supporting risk assessments. Where required, they will also act as the Approved/Authorized Person for conducting Risk Assessment and signing off Method Statements and Permits to Work.
The role requires a degree of flexibility and hands-on technical completion of planned and reactive maintenance. The Facilities Engineer is expected to assist with planning and development of facilities requirements and may complete the manual labor within this unique defined job description. Developing relationships with client clinical key stakeholders is key to the success profile of this role.
B. Organizational Relationship
This position reports to the Director of Facilities, Engineering and is responsible for communicating effectively with other individuals within all departments. This position works closely with process Engineering and Equipment & Production Engineering personnel as needed to complete tasks.
C. Duties and Responsibilities

  • Specific Job Duties/Responsibilities
  • Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Parts 820 and 1271; American Association of Tissue Banks (AATB); International Organization of Standardization (ISO); European Medical Device Directives (MDD); and Canadian Medical Device Regulations, as applicable, and adhere to standards and regulations to help the company lead the Medical Device and Biologics industries in quality practice
  • Adhere to Xtant Standard Operating Procedures (SOPs) and safety protocols, FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and Devices; operate in compliance with FDA, AATB, ISO, and Occupational Safety and Health Administration (OSHA) Standards
  • Develop and maintain an understanding of the Xtant products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
  • Ensure operations are efficiently maintained by completing project functions on time and budget
  • Provide campus-wide consultation, coordination and professional leadership in the planning, development, and implementation of construction and/or repair programs within the broad area of engineering specialty
  • Adapts and/or modifies standard engineering techniques to develop integrated, original, and creative model design concepts in response to engineering problems and development needs within the discipline
  • Provides expert consultation and coordinates and integrates activities with representatives of other engineering disciplines as required on a project basis
  • Manage and assist utility distribution and generation equipment and systems performance
  • Assist Production Engineering in installation, repair, maintenance and alteration of production support machineries, equipment, and building
  • Assist in the maintenance of facilities building services
  • Conduct analysis and propose procurement of facilities services
  • Recommend solution and prepare relevant reports to ensure proper selection of outsourced services
  • Plan, implement and maintain the infrastructure and equipment of buildings and facilities
  • Perform analyses of operational processes, resource allocation, energy use, and safety processes, and recommend and implement improvements
  • Determine facility and equipment specifications
  • Analyze project costs and prepare budgets
  • Design and oversee the implementation of facility expansion, layout, various systems, and quality controls
  • Develop process plans and optimize resource allocation
  • Plan and coordinate infrastructure and equipment maintenance schedules and activities
  • Coordinate and oversee contractors performing maintenance activities
  • Ensure compliance with relevant regulations, building codes and health and safety standards
  • Prepare reports and compliance documentation
  • Financial Responsibilities
  • Submit timely expense reports and abide by the Expense Reimbursement Policy
  • Training
  • Participate in training plans and programs and complete in a timely manner within set deadlines
  • Complete required training prior to attempting to perform a task
  • Maintain required training documentation
  • Management
  • This position may supervise others
  • Document Control and Record Control
  • Assist in the completion and retention of documentation pertaining to all SOPs as required
  • Legibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as required
  • Maintain information in physical and electronic files as required
  • Train on and demonstrate proficiency in Xtant Medical’s document control system
  • Other duties as assigned
  • *

Performance of Duties*

  • Complete required training, including initial orientation and environmental health and safety training, prior to performing tasks. Keep training up to date
  • Perform all duties according to established procedures and follow appropriate safety precautions and measures
  • Conduct himself/herself in a professional and courteous manner in all aspects of interaction with fellow employees, surgeons, staff, and end users
  • Maintain a clean and safe working environment at all times
  • Must maintain confidentiality of donor and recipient information according to HIPAA

D. Job Requirements

  • Education/Credentials Experience & Training
  • Bachelor’s degree in Industrial Engineering/Industrial & Management Systems Engineering or relevant experience is required
  • Experience with SolidWorks is preferred
  • Project management skills are preferred
  • Technical Requirements/Skills
  • Knowledge and understanding of engineering principles, methods, and techniques within broad area of specialty
  • Knowledge of the building process and construction principles
  • Knowledge of relevant regulations and building codes
  • Knowledge and understanding of all relevant federal and state laws, regulations, and operating guidelines
  • Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community
  • Ability to provide technical leadership and project management to engineering projects of high complexity and broad ranging scope
  • Ability to adapt and modify engineering techniques and develop original model concepts within area of professional expertise
  • Ability to manage and coordinate the work of technical consultants and/or contractors
  • Ability to develop and manage project budgets, and to track and project costs using computer spreadsheet techniques
  • Knowledge and understanding of allied disciplines and ability to coordinate interdisciplinary teams

3. Managerial Experience

  • N/A

4. Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications

  • Ability to analyze complex engineering problems and devise creative and effective solutions
  • Ability to write, review, and edit technical reports and SOPs
  • Ability to communicate effectively both orally and in writing
  • Ability to multitask
  • Must possess excellent organizational skills and strong attention to detail
  • Must possess excellent communication skills (verbal and written)
  • Intermediate computer skills required such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
  • Ability to investigate and analyze information and to draw conclusions under moderate supervision

5. Working Conditions

  • Working conditions are normal for an office environment. Standard office hours are Monday – Friday; 8:00 am – 5:00 pm. Work will require occasional weekend/evening work and travel
  • Work may require long periods of sitting, standing, and working at a computer
  • Working conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments
  • Duties may include contact with human tissue, blood, bone, and fluids (Clinical Laboratory, Donor Services, Engineering, Processing, Packaging and Labeling, etc.). Working in PPE such as cleanroom suits, with face shields and masks as necessary
  • May work in conditions leading to minor personal discomfort such as in temperatures above or below personal comfort levels
  • 6. Health and Safety*
  • Must adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company products
  • This position will sometimes be required to wear personal protective equipment (PPE), including laboratory coat, scrubs, and gloves, etc.
  • Will require experience or training in the routine handling of chemicals and biohazards.
  • May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable
  • Hepatitis B vaccine is highly recommended and provided to employees who may have contact with human tissue at no cost to the employee. Any employee who declines a Hepatitis B vaccine will be required to sign a waiver

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Note: *_ This Job Description is not designed to include a detailed listing of the activities, duties or responsibilities that may be required of the employee. This job description does not constitute an employment contract, implied or otherwise, and is subject to change by the employer as the needs of the employer and requirements of the job change.
** This position does not offer current or future H-1B Visa Sponsorships **

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Xtant Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training._

Job Type: Full-time

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