29 days old

Engineer II - Essent Biologics

AlloSource
Centennial, Colorado 80111
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift

For more than 20 years, AlloSource’s allografts have been the biologic solutions our surgeon customers use to deliver better care to their patients. As one of the largest and most respected nonprofit tissue banks in the United States, AlloSource develops, processes and distributes over 200 types of life-saving and life-enhancing allografts for use in a variety of medical procedures. Our commitment to honoring the gift of tissue donation motivates us to develop innovative allografts and lead the way in cellular and tissue therapies.


Summary:

The Engineer II provides technical support to the Operations, R&D, Quality, Facilities/Equipment Management and Customer Business Development departments with general supervision. This position is responsible to lead or support in existing operation equipment/processes/systems on a day to day basis, including but not limited to process/product engineering, documentation, equipment validation/verification, specification creation and resolution of production processing issues to comply with GxP. This may include supporting projects, developing new equipment, processes, and systems. This Engineer II's duties include the communication with all stakeholders to ensure adequate input is achieved and status understood.

 

Essential Duties and Responsibilities:

  • Supports operational/departmental process and product development/improvements.
  • Applies engineering skills to address technical problems and identify risk.
  • Develops documentation to improve and provide consistency on company procedures and in support of processes/equipment.
  • Write and execute verification / validation protocols as part of the design control / stage gate process.
  • Assist in new product / process projects using design controls.
  • Work with project management to manage projects effectively and provide realistic timelines.
  • Interfaces daily with most departments within Essent Biologics and AlloSource. Will work directly with suppliers. May have supervised interface with customers and the FDA.
  • Exercises good engineering judgment when executing daily job duties. Considers critical regulatory requirements in decisions involving end user/customers and technician safety. It is critical that all products produced be of the highest possible quality.
  • Reviews work to ensure errors do not result in serious injury to a customer, injury to an AlloSource technician, regulatory non-compliance, excess expense to the company.
  • Adheres to and promotes proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.
  • May perform other related duties and responsibilities as assigned.

Requirements

Requirements:

  • Bachelor’s degree in Engineering or technical area
  • 3-7 years’ industry experience (e.g. manufacturing processes, design, sustaining engineering, validation, technical service)
  • Proficiency in Microsoft Office applications
  • Working knowledge of design controls and validations

 

Preferred Experience:

  • Master’s degree in Engineering or technical area
  • Proficiency in Minitab
  • Previous experience at tissue bank, medical device or other FDA regulated industry
  • Previous training or experience with root cause analysis, lean six sigma, statistical techniques, and/or quality systems


Pay: $59,850/yr - $73,250/yr based on relevant years of experience. 10% target Bonus Program based on individual and company metrics.

Shift: Monday-Friday; 8:00am – 5:00pm

Benefits: Generous Time Off Policy, Paid Sick Leave, 9 paid Holidays, Retirement Plan, onsite Health Care clinic, Wellness Program, Life Insurance, AD&D, Short & Long Term Disability, and more!

Location: 6278 S. Troy Circle, Centennial, CO 80111

 

For consideration you must apply online, submit a current resume and meet the minimum requirements. All offers are contingent upon a background check, drug screen and other contingencies may apply depending upon the position. Candidates within a 50 mile radius of the hiring zip code may receive first consideration. If you require special accommodations, please contact us at 720-873-0213.

 

Equal Opportunity Employer/Veterans/Disability

 

AlloSource uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

Categories

Posted: 2021-01-31 Expires: 2021-03-02

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Engineer II - Essent Biologics

AlloSource
Centennial, Colorado 80111

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