Manufacturing Technician

At Tepha, our vision has always been a simple one – to be the leader in tissue engineering and regenerative medicine. We advance surgeons' ability to make structural repairs to the human body with unrivaled biomaterials that become much like the tissue that surrounds them; products that can be tailored to meet untold applications across the spectrum of surgical repairs. 

Founded in 1998 and headquartered in Lexington, Massachusetts, Tepha is currently seeking Manufacturing Technicians to perform multiple tasks within the Manufacturing discipline, including product manufacturing and administration of the document control and maintenance programs, among others. This position also requires the setup, operation and maintenance of various types of extrusion or related equipment.

Please note, manufacturing work at Tepha is spread across three shifts that rotate every two weeks and every Technician must be able and willing to work all three shifts:

• 1st shift runs from 7:00 am until 3:30 pm
• 2nd shift runs from 3:00 pm until 11:30 pm
• 3rd shift runs from 11:00 pm until 7:30 am
  
  

Duties & Responsibilities

• Set up and operate various extrusion lines, e.g., Monofilament, Compounding, etc. 
• Assist Manufacturing Engineering with process and product validation. 
• Contribute to the administration of the document control process. 
• Create and/or approve Manufacturing documents. 
• Create and maintain accurate batch records and lot history records. 
• Conduct feasibility studies and perform extrusion process validations. 
• Analyze process data and ensure conformance to requirements. 
• Coordinate with the Shipping and Receiving team. 
• Improve/modify MFG lab for ease of routine manufacturing operations. 
• Maintain MFG supply inventories. 
• Maintain inventory for raw material, supplies, and spare parts. 
• Maintain/repair of manufacturing equipment 
• Process and package finished goods, e.g mesh and film 

Knowledge, Skills & Abilities

• High school diploma required; Associate’s or Bachelor’s degree preferred.
• A minimum of 2 years in a Manufacturing function, preferably in the medical device industry or equivalent.
• Knowledge and familiar with Good Manufacturing Practices (GMP) and ISO 13485:2003 and/or ISO 9001 
• Good mechanical aptitude 
• Well organized with good record-keeping skills 
• Ability to work well with others and to communicate effectively 
• Ability to read and understand engineering documentation 
• Familiarity with PC based software for data entry and report generation 
• Experience using SolidWorks or equivalent helpful. 
• Experience and knowledge of extrusion processes and theory 
• Experience with process control and validation activities 
• Knowledge of plastics processes I processing equipment 
• Knowledge of statistical techniques for generation and analysis of data a plus 

Please note, this is a plant-based position in Lexington, MA.
 
At Tepha, we strive to maintain the cultural aspects that make us special as our organization continues to evolve. In additional to competitive salaries and bonuses, new hire equity, a 4% 401(k) match and 100% company-paid premiums for health, dental and vision insurance, we offer unmatched scientific technology, stimulating work experiences, passionate colleagues and Greater Boston’s most competitive summer bocce league.
 
Sound good? We invite you to click ‘apply’ and begin a conversation with us. #Tepha

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Tepha Medical Devices about our openings. All resumes submitted by search firms/employment agencies to any employee at Tepha via email, the internet or in any other form and/or method will be deemed the sole property of Tepha, unless such search firms/employment agencies were engaged by Tepha and a valid agreement with Tepha is in place. In the event a candidate who was submitted outside of the Tepha agency engagement process is hired, no fee or payment of any kind will be paid.