Principal Engineer - Process Manufacturing

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Design, develop, implement and improve manufacturing processes to produce quality medical device products and systems cost effectively.  Provide manufacturing engineering expertise to develop, document and implement required procedures and documents. This position is located in our Ave Maria, FL location for manufacturing. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Lead project teams to introduce new, quality medical device products and systems cost effectively with a propensity toward speed.
• Lead collaboration with Mfg. Engineers, Design Engineers, Quality Engineers, Packaging Engineers, Buyers, Planners, Sterility Engineers, Assembly Engineers, Metrologists and Production to ensure quality and cost-effective new product development and introduction into manufacturing.
• Lead the use of techniques to “get it more right” the first time.
• Base conclusions on analytical methods, rational logic, and critical thinking.
• Leverage Project Management tools to establish a plan and deliver reliable, predictable results.
• Seek, identify, mitigate, and control through sound methods and techniques sources of process variation and process parameters that significantly influence process outcomes.
• Lead the development, effectiveness evaluation, and implementation of Work Instructions and associated manufacturing documentation.
• Establish a customer focused approach, external and internal customers.
• May supervisor other Engineering, Prototype or Programming personnel.

Education and Experience:

• Bachelor’s degree in Engineering, Science or Mathematics required, MS preferred.
• 12 years of relevant manufacturing engineering experience required.
• Orthopedic Medical Device manufacturing engineering experience required.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Familiarity with the requirements of FDA 21 CFR Part 820, ISO-13485, ISO-14971, and cGMP. 
• Working knowledge in Design for Six Sigma, and Lean Six Sigma Manufacturing techniques. 
• Ability to demonstrate process improvement skills. 
• Experienced user of MS Office Suite.
• Experienced user of CAD software such as: Solid Works, ProE, NX.
• Experienced user of CAM software such as: Partmaker, Mastercam, NX, Vericut.
• Familiarity with cleanroom practices.
• Project management skills, PMP certification preferred.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. 

Mathematical Skills:

Ability to comprehend and apply mathematic and descriptive statistic principles to the degree required to perform the job based upon job requirements. 

Language and Communication Skills:

Strong people skills to constructively influence. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.   

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 10 pounds.

Vision Requirements:

Visual acuity necessary to do the job safely and effectively. 

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.  While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock.  The noise level in the work environment is usually moderate.

Arthrex 2023 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 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 or protected veteran status.