Medacta® is a Swiss-based orthopedic company founded in 1999, renowned for its innovative products and surgical techniques. Notably, they pioneered the Anterior Minimally Invasive Surgery (AMIS®) technique for hip replacements, MyKA™ Kinematic Alignment Platform for knee replacement, and NextAR™ Augmented Reality Surgical Platform for use in shoulder, spine, and knee procedures. Leveraging their extensive orthopedic expertise, Medacta introduced MySolutions technology, which provides surgeons with highly personalized pre-operative planning and implant placement methodologies. Utilizing advanced personalized kinematic models and 3D planning tools, MySolutions enhances surgical precision in hip, knee, shoulder, and spine procedures. Medacta's blend of orthopedic expertise and cutting-edge technology drives continual advancements in the field, enhancing patient care worldwide.

The Quality Engineer, NPI and Technology position coordinates the development of verification for current and new technologies, as well as supports the introduction of new products to the US market.  This includes coordination and completion of necessary product priorities, development and implementation of department processes and procedures, and support for the Medacta USA operations, R&D, marketing, and sales teams.

 

Educational Requirements:

Bachelor’s Degree in Life Science or Engineering field.

 

Experience Requirements:

2 - 3 years’ experience in the Medical Device, Automotive, or any related electronics industry.

 

Required Skills and Abilities:

• Experience with equipment validations and new product introduction.
• Strong interpersonal and communication skills. 
• Ability to communicate effectively both verbally and in writing. 
• Highly organized and detail oriented.
• Ability to convey complex information in understandable terms to individuals throughout all levels of the company. 
• Ability to analyze and solve problems. 
• Ability to handle multiple tasks concurrently.
• Excellent time management skills. 
• PC, Microsoft Office software suite, general office equipment.
• Physical Requirements:
  • Sitting: Extended periods at a desk or workstation.
  • Standing and Walking: Frequent movement within the office.
  • Lifting and Carrying: Light to moderate lifting of office materials.

Additional tasks may require reaching, manual dexterity, and visual acuity.

 

External: N/A

Internal: Sales Personnel, Marketing, Product Development, Finance, Administration, Customer Service, Operations, Medical Education, Clinical Research, Human Resources, and Medacta International Personnel worldwide.

Travel requirements: Some travel to industry conferences or the Franklin office may be necessary.

Extent of Confidential Information: Any Protected Health information.

Reporting: Quality updates to internal colleagues.

 

• Supports New Technology verifications and development of actions required for future systems.  This includes support for the current systems receiving verification, servicing, and upgrades from the field to ensure software is running correctly, accessories are connecting and functioning, and the system functions correctly and any damage is identified.
• Supports various market releases; this role will also focus on understanding and identifying all quality and operational requirements.  Such as:
  • Coordination with internal departments to ensure all necessary customer requirements are met.
  • Coordination with Medacta USA logistics and quality to ensure BOM's are finalized and accurate, all operational input is understood and planned for (i.e. lubrication, instrument cleaning input, potential damage types, necessary operational quality alerts are setup / maintained), all damage instruments are identified and processed correctly to ensure necessary damage is communicated to headquarters and any complaints are initiated.
  • provide quality support for any event investigations / Corrective Actions, hospital requests, product swaps, and other actions as needed.  This includes monitoring of surgeon feedback / field issues for new products.
• Develops and implements standard processes to ensure consistent and repeatable results.
• Identifies opportunities to reduce common deficiencies from FDA.
• Ensures that all quality system activities are completed in compliance with 21 CFR Part 820 regulations.

OCCASIONAL DUTIES

Other duties may be assigned at Medacta USA’s discretion.

 

The above statements are intended to describe the general nature and level of work being performed by people assigned to this position. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.