Principal Engineer, R&D - Process & Validation - Defined Term

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Steritec Products Inc., a member of the Getinge Group, manufactures sterilization and cleaning medical device consumables using ink technology. We manufacture and print highly specialized proprietary inks that undergo specific color changes when exposed to different sterilization conditions in hospital and industrial/pharmaceutical sterilizers.

We are located in the beautiful Inverness Business Park in Englewood, CO. We offer a generous benefit package (medical, dental, vision, life, 401(k) as well as company-paid holidays) all effective first day of employment!
 

This is a Fixed Term assignment that is slated to run through December 2026. 
 

The Principal Engineer - Process & Validation position is an on-site, full-time position. Hours are Monday – Friday, 8:00am – 4:30pm (with some flexibility). 

 

Job Function Summary:
Assists with current processes, and development of new processes in support of R&D, Manufacturing and Product Development.  Provides support and guidance on validation activities related to manufacturing/test equipment and processes. Helps in establishing Process KPIs and establish systems for continuous monitoring. 

Job Functions: 
•    Works to improve efficiency and effectiveness of manufacturing and other facility processes.  
•    Provides Process Design Engineering guidance to R&D, Manufacturing and Product Development.
•    Assists with process flow documentation and design including process steps, workflow and material handling techniques.
•    Assists with applying statistical analysis techniques.
•    Identify metrics to measure and make visible production performance for quality and efficiency. 
•    Assists with R&D protocols for new product introduction.
•    Provides input to new equipment designs with emphasis on concurrent engineering and improved productivity techniques.
•    Assists with process documentation generation and maintenance.
•    Participates in new equipment qualification and validation.
•    Participates in process and test method qualification and validation.
•    Assists in special projects as needed.  
•    Contributes to team effort by accomplishing related duties as requested.

 

Required Knowledge, Skills and Abilities: 
•    Successful project management experience is required.  
•    Experience in problem solving and troubleshooting using statistical and analytical tools required. 
•    Excellent communication skills, ability to work in a team environment and ability to lead a project team. 
•    Demonstrated knowledge and application of Lean concepts preferred.
•    Demonstrated creative problem solving in a regulated manufacturing environment.
•    Knowledge of statistical techniques and sampling for process validation and process monitoring is desired.
•    Experience in analysis of manufacturing processes, development of process improvements and validation of process changes desired.

Minimum Requirements:  
•    Bachelor’s degree in engineering, or equivalent.  
•    Minimum 10 years progressive experience in a medical device environment. 
•    Basic computer skills including word processing and spreadsheet experience required.  
•    Strong MS computer skills including MS Office Suite (Word, Excel) are required.
•    Working knowledge of Minitab preferred.
•    Experience with Agile PLM or other documentation management system desired.

Quality Requirements: 
•    Build Quality into all aspects of work.
•    Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to your job function).
•    You 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.
•    Must practice verbatim compliance (exact compliance, no interpretation) with corporate Quality and Regulatory procedures (As applicable to your job function).
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