Engineer- Test Methods-Medical Device

1 month ago


Thousand Oaks, United States Infotree Global Solutions Full time

The Engineer, in Physical Methods, is responsible for engineering activities required for the development /

qualification / validation and transfer of physical GMP test methods for combination products, devices,

primary containers, and secondary packaging parts. The Engineer shall have the ability to work on

multiple projects at one time that may involve changes or new product, processes, tooling or equipment

introduction to improve quality and reliability and reduce cost. Phases of projects include: developing

combination product test methods, providing key experienced support for qualification, validation, transfer,

and life cycle support of methods for manufacturing, new product introduction, training, and production

support.


Responsibilities:

• Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and

injection devices.

• Work in teams to transfer new combination product test method and assembly

requirements to manufacturing, by developing six sigma processes and compiling

documentation for manufacturing assembly requirements.

• Develop, qualify, validate, and transfer new equipment, software, systems, and methods.

• Implement projects per Final Product Technologies and company procedures to ensure

projects are completed on schedule and within established budget.

• Provide experienced support for investigations as well as new process development

required to improve manufacturing operations.

• Coordinate test method development and delivery with selected contractors.

• Ensure that qualification parameters are met for product assembly requirements.

• Support development of cost estimates for new processes, gauges and equipment

development used in generation of capital request documentation.

• Generate procedures necessary to support department and new process equipment.

• Provide experienced training to individuals in the operation and maintenance of processes,

test methods and equipment introduced to Quality Control and/or the manufacturing

department (i.e. production operator, mechanics, process engineers).

• Participate in and assume responsibilities of team functions as assigned (i.e. Product

Improvement Teams).

• Generate/author and be responsible for the Test Method documents.

Gather test method requirements that result in equipment that operates safely and

considers ergonomic factors in the design

• Perform other duties as required by the Group Manager

• Align with the requirements, responsibilities, and authority as required

• Maintains integrated timelines collecting appropriate multi-functional details and work which

are aligned with the functional and project work

• Networks internally to ensure alignment, commitment to project objectives and timelines as

well as to ensure effective execution of projects



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