Hybrid Production Engineer I bei Xtant Medical

At Xtant Medical, our mission is to honor the gift of donation by allowing our patients to live as full and complete a life as possible. We are seeking a full time, exempt Production Engineer I to join our team on-site in Belgrade, MT. It offers a pay rate of $63,500k - $77,700k DOE and includes the benefits listed below. If you enjoy working as a team and want to grow your career, you've found the right place at Xtant Medical!

Benefits: 

• Medical - Dental - Vision
• Generous PTO Schedule
• Corporate Gym Discount
• 401(k)
• Well-Being Programs / LifeBalance Discount Program
• Life & AD&D Life Insurance
• Long-Term & Short-Term Disability
• Tax Savings
• And more...

Responsibilities of the Production Engineer I:

• Develop and maintain an understanding of relevant industry standards and regulations including but not limited to 21 CFR 820, 21 CFR 1271, AATB, MDSAP (per jurisdictional requirements), and ISO 13485, ensuring compliance with these requirements across the organization.   
• Actively contribute to the fulfillment of Xtant Medical’s mission, values and quality policy
• Maintain a safe, clean work environment and ensure proper disposal of hazardous and non-hazardous waste according to OSHA guidelines and Xtant Medical standard operating procedures (SOP)
• Develop and maintain an understanding of Xtant Medical products 
• Understand the interaction of departmental activities with the Quality System and their impact on the production of medical devices and human cells, tissues, and cellular and tissue-based products (HCT/Ps)
• Adhere to Xtant Medical SOPs, Good Documentation Practices (GDP), and safety protocols
• Learn the Equipment and Instrument Management Systems. Complete Equipment and Instrument Management functions as needed
• Track schedules and coordinate equipment maintenance and repairs, and internal/external equipment and instrument calibrations
• Maintenance and retention of equipment records
• Perform routine disinfection and cleaning of equipment and working areas
• Learn the Monitoring / Alarm Systems and properly respond to alarms
• Design parts that cannot be purchased “off the shelf” using specialized software programs
• Create CAD drawings for documents and Research and Development as requested
• Work closely with manufacturers/contractors to ensure work is completed properly and in a timely manner
• Ensure that all warehouse and shop areas are organized
• Assist in installation of new equipment
• Under supervision, assist with maintaining, repairing, and upgrading manufacturing/processing equipment as needed
• Work closely with fabricators to design various systems and components as needed for internal use
• Install and maintain general facility equipment
• Assist in replenishment and receiving of new/replacement inspection gages
• Maintain inventory counts and perform routine inventory level inspection/replenishment of equipment/facility spare parts and components
• Assist with the design, building, and maintenance of processing cleanrooms
• Assist with the purchase, installation, usage, and maintenance of complex equipment
• Assist with periodic maintenance of cleanrooms and controlled environments, including complete shutdown to, for example, change all filters; upkeep compressed air ports; regulators and filters; caulk all areas; replace hardware; service lights; ensure proper function of all doors; check outlets and outlet covers; inspect all door handles; and inspect and maintain joints/seams
• Work on multidisciplinary teams to develop new or improve existing biologics products
• Assist in developing innovative ideas to upgrade facilities, products, and equipment
• Work on-call shift as needed
• Other duties as assigned

Job Requirements

• Bachelor’s degree in Engineering from an accredited college or university is required (Mechanical or Electrical Engineering degree is preferred)
  • Experience with SolidWorks is preferred
  • Medical industry experience is preferred
  • Experience with power and hand tools is preferred
  • Experience with company SOPs, document control and retention and regulated industry environment is preferred
  • Experience with CNC programming and operation is preferred
  • Must be able to reason independently and work with minimal guidance
  • Ability to interpret data and make sound judgements based on those interpretations
  • Must deal effectively with a wide variety of personalities and situations requiring tact, judgment, and poise
  • Must be able to adapt to quickly changing priorities and schedules
  • Ability to maintain good working relationships with all co-workers and the general public and use good judgment in recognizing scope and authority
  • Must possess mobility to work in a standard office setting and to use standard office equipment
  • Advanced mechanical aptitude, electrical/electronic knowledge
  • 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

Working Conditions

• This position is based in an office environment
• Standard work hours are Monday – Friday; 8:00 am – 5:00 pm, with occasional overtime or weekend work based on project/production needs
• This position is based on-site in Belgrade
• Working conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments with varying temperatures
• 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 suites, with face shields and masks as necessary
• 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. 
• 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

Physical Requirements

• Ability to sit, stand, and work at a computer for prolonged periods
• Ability to lift, carry, push or pull items of varying weight, typically up to 60 lbs. 

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 sponsorship.

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.