Sr. Engineer, R&D Testing & Validation

 

 

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.

 

 

Job Purpose and Function:
The Sr. Engineer, R&D Testing and Validation position provides skilled technical insight to enable final product design by building product testing plans, testing prototypes and providing analysis aligned with global product qualification requirements.

In addition, the Getinge Aseptic Solution (GAS) Engineer, works with other internal and external team members to ensure timely and quality testing and data analysis in support of all product commercialization efforts. This is a hands-on position that requires a strong mechanical engineering background.

 

Key Duties and Responsibilities:
The responsibilities include but are not limited to:

• Responsible for completing all R&D protocol generation, test execution, and protocol event reporting.
• Lead and complete Design Verification and Validation test planning, execution, interpretation, and reporting.
• Design, conduct, and interpret experiments to support all GAS products and technologies, including aseptic Connectors, Fillers, and Filler-related consumable product development, evaluation, and verification.

• Apply scientific and technical test acumen toward the development of new test methodologies and improvement of existing methodologies, as well execution of test method validations.

• Provide technical oversight and leadership on matters regarding device testing for all product groups to include R&D Engineering, Quality, Manufacturing/Production, and Regulatory.

• Identify areas of improvement for test methods by staying current with best practices.
• Coach and mentor laboratory technicians or other technical personnel as required.
• Coordinate and run project meetings as needed.
• Contributes to team effort by accomplishing related duties as requested, such as a Subject Matter Expert to departments outside of business area of primary responsibility.

• Develop budget and justification for new equipment and upgrades to existing equipment.
• Design and execute equipment qualification plans.
• Lead special projects as needed.
• Perform other projects and duties as assigned by the Program Manager for the overall benefit of the organization

 

Required Skills and Abilities:

• Ability to work independently and perform all necessary testing procedures in a timely manner
• Excellent problem solving and analytical skills
• Excellent organizational and planning skills with a solid attention to detail
• Effective communication skills and excellent interpersonal skills
• Open and collaborative working style; must be comfortable working in an environment where ideas are shared
• and challenged
• Ability to stay focused on the requirements of the customer and process controls
• Being accountable and willing to hold others accountable

Education and Experience:

• Bachelor’s degree in mechanical engineering, biomedical engineering, or similar technical discipline required
• Minimum of 5 years of experience testing and validation of new products in development
• Excellent mechanical aptitude or skill such as working knowledge of pumps, motors, valves, materials, etc. to be able to assemble machine components, troubleshoot, repair and calibrate equipment

• Knowledge of microfluidics and interaction with mechanical forces
• Basic math (algebra) skills
• Proficient in Microsoft Office

Physical Requirements:

• Employee is required to sit, stand, walk, and move around the facilities to include the lab/testing areas