Overall Purpose

The Senior Sterility Assurance Engineer is responsible for supporting the terminal sterilization [Ethylene Oxide (EO), Gamma Radiation, Electron Beam (e-beam), Gas Plasma and Steam] of medical devices in a global regulatory environment. The position will serve as a leader for Sterility Assurance, Manufacturing, Product Development and Regulatory Affairs on advance topics of sterilization.

The Project Sterility Assurance Engineer is responsible for supporting the terminal sterilization [Ethylene Oxide (EO), Gamma Radiation and Steam/Reusable Instruments] of medical devices in a global regulatory environment. The position will serve as leader in Sterility Assurance, as well as the organization, on advanced topics of sterilization, quality systems and process improvement.

Principal Responsibilities

Senior Sterility Assurance Engineer: 

1. Review and release of sterilization loads, which includes, but not limited to, the review of biological indicator test results, as appropriate.
2. Supporting the validation/ revalidation/ requalification of all MicroPort Orthopedics sterilization methods (i.e. EO, Gamma, E-beam, Gas Plasma and Steam) and ECA's.
3. Participating and advising on Product Development Projects.
4. Advise and interact with Regulatory Affairs on matters associated with sterilization.
5. Supporting the Environmental Monitoring and Sterility Assurance Testing Programs.
6. Conducting contract sterilization vendor and laboratory audits, as required.
7. Supporting special projects, as necessary. Performing other assigned tasks in support of the department, as needed.
8. This is a high-level, decision-making, and professional position in a technical environment.  It requires an advanced ability in problem solving, analysis, reasoning, and creativity in order to perform the duties expected.

Project Sterility Assurance Engineer:

1. Lead, mentor and coach sterility team
2. Review and release of sterilization loads, which includes, but not limited to, the review of biological indicator test results.
3. Supporting the validation/ revalidation/requalification of all MicroPort Orthopedics' sterilization methods (i.e. EO, Gamma and Steam/Reusable Instruments) and Environmentally Controlled Areas.
4. Participating and advising on Product Development Projects.
5. Advising and interacting with Regulatory Affairs on matters associated with sterilization.
6. Developing and working on strategic initiatives to advance corporate objectives.
7. Supporting the Environmental Monitoring and Sterility Assurance Testing Programs.
8. Leading audits of contract sterilization vendors, laboratories and vendors that manufacture sterile product for MicroPort Orthopedics, as required.
9. Supporting special projects, as necessary.
10. Performing other assigned tasks in support of the department, as needed.
11. This is a high-level, decision-making, and professional position in a technical environment. It requires an advanced ability in problem solving, analysis, reasoning, and creativity in order to perform the duties expected.

Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

Skills Requirements

• The candidate must exhibit a thorough knowledge of ethylene oxide and/or gamma sterilization concepts and requirements (i.e. ISO 11135 and ISO 11137).    
• The candidate must exhibit a thorough knowledge of cleanroom/ ECA and contamination control concepts and requirements (i.e. ISO 14644 and ISO 14698). 
• The candidate must exhibit a thorough knowledge of Sterility Assurance testing concepts and requirements (i.e. ANSI/ AAMI/ ISO 11737, ANSI/AAMI ST72, ANSI/AAMI/ ISO 10993, etc.) 
• Knowledge of medical device regulations (i.e. 21 CFR Part 820 and ISO 13485).
• Knowledge of packaging and product design issues as they related to sterilization.
• The candidate must display excellent leadership, communication, and interpersonal skills.  In addition, the candidate must be able to work on cross-functional teams, as well as independently (i.e. little to no supervision).
• Computer skills required including Microsoft Excel and Microsoft Word.

• Knowledge of calibration requirements preferred.

Accountability

This position is accountable for supporting the terminal sterilization of medical devices globally. Failure to maintain accountability for MicroPort's sterilization program may result in severe physically harm to a patient's well-being; in addition to have severe financial and regulatory repercussions to MicroPort Orthopedics Inc.

Experience Requirements

Senior Sterility Assurance Engineer: 5+ years of related experience required. Education and preferred experience may substitute for some of the requirements listed under Required Experience.

Required Experience       

• Ethylene oxide and/ or gamma sterilization experience.
• Cleanrooms/ Environmentally Controlled Areas (ECA) and contamination control experience.
• Sterility Assurance testing (i.e. Bioburden testing, Sterility testing, Endotoxin testing, EO residual testing, etc) experience.
• Technical writing experience (i.e procedures, protocols, final reports, sterilization equivalency, etc).

Preferred Experience

• Electron Beam, Gas Plasma or Steam sterilization experience.The candidate should exhibit knowledge of the sterilization requirements.

Project Sterility Assurance Engineer: 8+ years of related experience required. Education and preferred experience may substitute for some of the requirements listed under Required Experience.

Required Experience     

• Ethylene oxide and/ or gamma sterilization experience. The candidate must exhibit a thorough knowledge of ethylene oxide and/ or gamma sterilization concepts and requirements (i.e. ISO 11135 and ISO 11137).        
• Cleanrooms/ Environmentally Controlled Areas (ECA) and contamination control experience. The candidate must exhibit a thorough knowledge of cleanroom/ ECA and contamination control concepts and requirements (i.e. ISO 14644 and ISO 14698).
• Sterility Assurance testing (i.e. Bioburden testing, Sterility testing, Endotoxin testing, EO residual testing, etc.) experience. The candidate must exhibit a thorough knowledge of Sterility Assurance testing concepts and requirements (i.e. ANSI/ AAMI/ ISO 11737, ANSI/AAMI ST72, ANSI/AAMI/ ISO 10993, etc.) 
• Technical writing experience (i.e procedures, protocols, final reports, sterilization equivalency, etc.).

Preferred Experience

• Steam/ Reusable Instrument sterilization experience. The candidate should exhibit knowledge of the sterilization requirements.

Education Requirements

Bachelor’s Degree in Life Sciences, Engineering or a related discipline required; Master's Degree preferred

**All candidates: Please completely fill out the online application and attach a resume that includes your current role, experience, education and contact information.**

For internal reference, the Senior Sterility Assurance Engineer is a level 6 and the Project Sterility Assurance Engineer is a level 7.

Search Firm Representatives Please Read Carefully: MicroPort Orthopedics. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MicroPort via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MicroPort. No fee will be paid in the event the candidate is hired by MicroPort as a result of the referral or through other means.