Principal Engineer - Quality Process Validation - Defined Term - Englewood, CO

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 assignement that is slated to run through December 2026.

The Principal Engineer - Quality 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.

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.
* Develop manufacturing processes; process flow documentation and design including process steps, workflow and material handling techniques.
* Assists with applying statistical analysis techniques and lean manufacturing principles to drive operational efficiencies
* Develop new manufacturing methods and procedures.
* 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, and revalidation
* Participates in process and test method qualification and validation.
* Contributes to team effort by accomplishing related duties as requested.
* Update and develop new SOPs.
* Reduce process risks and increase manufacturing process efficiency.
* Quality and Engineering Project work as assigned.

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.
* Ability to follow SOP and develop, update and validate existing manufacturing equipment.
* Experience with Automated system validation and development of new techniques.
* Develop project plan and execute project plan.

Minimum Requirements:
* Bachelor's Degree in Engineering, or equivalent.
* Minimum three to five year progressive experience in a medical device environment.
* Experience in analysis of manufacturing processes, development of process improvements and validation of process changes desired.
* Knowledge of statistical techniques and sampling for process validation and process monitoring is desired.
* 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).
* 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 local Quality System and Regulatory procedures (As applicable to your job function).
* If your job description requires customer facing activities, you must thoroughly understand and comply with the Customer complaint reporting process and complaint procedures (As applicable to your job function).
* Must be able to promptly report any non-compliance issues to Director QA, RA, Compliance officer or appropriate administrator, including the Compliance Hotline.
* Must be competent with 21 CFR 820 and any other applicable federal regulations, and Quality standards (As applicable to your job function).

Environmental/Safety/Physical Work Conditions:
* Ensures environmental consciousness and safe practices are exhibited in decisions.
* Duties are mainly performed in an office environment.
* Duties may be required to be performed in a controlled environment following specific gowning procedures.
* May work extended hours during peak business cycles.
* The individual must occasionally lift and/or move up to 15 lbs.
* Ability to utilize computer and telephone equipment and other related office accessories/devices to complete assignments.
* While performing the duties of this job, the employee is frequently required to stand, walk and sit.
* The employee must have use of hands to finger, handle or feel objects, tools, or controls; reach with hands and arms; speak and hear.
* Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

The physical demands described here are 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.

Supervision/Management Of Others: N/A

Internal and External Contacts/Relationships:
* Internal: Team members (including contractors), all Getinge colleagues including the executive and leadership team, Finance, Purchasing, Quality, R&D, Logistics and Inventory Control teams. Follow up with all levels of management for clarification/approval on reports as needed.
* External: Contractors, consultants, vendors, 3rd party providers, etc.

Disclaimer:

All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.

This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position, it is not an exhaustive list of all responsibilities, duties and skills required for the position.

Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.

Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Continued employment remains on an "at-will" basis.

Salary Range: $160k-$170k annually

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.