Engineer, Process/Validation

Job Overview

Assist with the development & optimization of new manufacturing processes and equipment that will be or has been transferred to production for commercial release.    

Job Responsibilities and Essential Duties:

• Work with other engineers to develop & optimize processes required for new products.
• Prepare protocols and reports for Installation Qualifications (IQ), and Operational Qualifications (OQ), Test Method Validations (TMV), and Performance Qualification (PQ). 
• Execute protocols to complete Installation Qualifications (IQ), and Operational Qualifications (OQ), Test Method Validations (TMV), and Performance Qualification (PQ). 
• Assist with preparation of process risk documentation (pFMEA).
• Assist / Coordinate pilot production / pre-release manufacturing.
• Work closely with Manufacturing to release new processes and equipment into production.
• Work closely with Manufacturing to support new processes and equipment that have been recently released into production.
• Assist with training efforts on new equipment and processes. 
• Assist with creating and implement required documentation including but not limited to; equipment history files, manufacturing procedures, test methods, BOM’s, routings, etc.
• Responsible for change orders (ECO/DCO’s) required to release and/or update controlled items.
• Maintain compliance to Quality System and regulations for new processes and equipment.
• Assist in special projects as needed. 
• Contribute to team effort by accomplishing related duties as requested.

Required Knowledge, Skills and Abilities:

• Problem solving / troubleshooting skills.
• Excellent communication skills with the ability to prepare written reports.
• Able to work in a cross functional team environment.
• Computer skills including MS Office Suite (Word, Excel, etc.).
• Experience with developing and optimizing new manufacturing processes preferred.
• Experience with introducing new equipment / processes into production preferred.
• Experience with process control & statistical analysis techniques preferred.

Minimum Requirements:  

• Bachelor’s Degree in Engineering
• Minimum 3 years experience medical device experience

Quality Requirements:  

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions: 

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Duties are performed in an office environment and within manufacturing spaces as required.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.