Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer II – Laboratory Operations and Process. This individual will be responsible for managing operations and efficiencies of the Orthopedic Research Biomedical Engineering Laboratory and ensure the procedures, equipment, and personnel are compliant under the Quality Management System. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Primary Duties and Responsibilities:

• Optimize the lab environment for the Biomaterials Research, Biomechanics Research, and Biomechanical Testing Teams.
• Manage all equipment maintenance and gauge calibrations.
• Track usage, forecast, and maintain lab supply inventory and purchasing.
• Provide a point of contact for all facilities, IT/GIS, EH&S, and outside vendors.
• Manage lab safety trainings and provide/promote a safe laboratory environment, including maintaining PPE supplies.
• Maintain, update, and author quality documents within the QMS document management system.
• Verify training activities and maintain training records for lab personel.
• Represent the Research Department during internal and agency audits of the laboratories.
• Complete NCR and CAPA activities including disposition plans, evaluations, and action plans.
• Assess quality risks and implement mitigation strategies.
• Lead equipment validation activities and process documentation (IQ/OQ).
• Analyze lab activities with respect to compliance to ISO 13485 and other applicable regulatory or quality standards, and make change recommendations to departmental leadership.
• Participate in training current and future Biomedical Engineering employees.
• Manage priorities and deliverables for multiple simultaneous projects per determined schedule and respond to special assigned projects as needed.
• Assist Biomedical Engineering Team members with research activities, including but not limited to sample preparation, testing, and data analysis
• Maintain accurate records.
• Track lab metrics and provide reports to the Biomedical Engineering Leadership.

Knowledge and Skills:               

• All previous plus:
• General knowledge of orthopedic devices and surgical procedures.
• Proficient at Good Laboratory Practices and Good Documentation Practices.
• Working knowledge of mechanical and chemical test methods, able analyze data, and perform statistical analyses.
• Working knowledge of ISO 13485 and applicable Quality Systems and regulatory standards and requirements.
• Operates successfully within the Arthrex QMS.

Education/Experience:           

• Bachelors Degree in Engineering required. 
• 2 years of scientific laboratory or quality engineering experience required, OR 1 years experience with a Masters Degree, OR PhD.

Machine, Tools, and/or Equipment Skills:

• PC and software as needed, including MS Office Suite.  Able to operate and maintain standard surgical tools and equipment.  Ability to understand mechanical and chemical testing devices, their use, and their upkeep.

Language and Communication Skills:

• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. 
• Ability to verbally communicate ideas and issues effectively to other team members and management. 
• Ability to write and record data and information as required by procedures.

Physical Demands:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 70 pounds. 

Work Environment:

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The area that this job is performed in is a general office or open cubicle/workstation environment, and a laboratory work environment.  The noise level in the work environment is usually moderate. 

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.