Product Quality Engineer: Ace Recruiters

Opportunity for a Product Quality Engineer in the Product Development of medical devices. The company is located in Palo Alto, CA and the position is a temp to possible perm.

Position Description:

Attached to the Product Development department this position is directly involved in the development, qualification, validation and continuous improvement of biomedical device manufacturing processes and equipment.

Skills and Duties:

The candidate in this position will be expected to apply experience of manufacturing engineering to bring processes into validated and qualified production within the requirement of standard biomedical industry practices. There will be direct involvement in the establishment of manual, semi-automated and fully automated production of biomedical devices.

The incumbent will be expected to be able to research materials, equipment, machinery, tools, techniques, vendors and concepts rapidly in order to understand and present such data and understanding in documentation or verbally to management or a group clearly and effectively.

The incumbent will be expected to be able to install, validate, qualify and continuously improve the manufacturing process of biomedical devices. As part of an intermediate engineering role the incumbent will also be expected to assist those of lesser experience and to rapidly learn from those with greater experience to achieve a similar level of ability.

Responsibilities

Targets/responsibilities are the metrics of the success of the incumbent within this position. These will be the categories that determine the progression and future advancement of the incumbent.

The responsibilities of this position are;

• Mechanical installation, fabrication and assembly skills
• Integrating electrical, fluidic, pneumatic and mechanical mechanisms
• Report Generation skills
• Documentary skills in recording equipment history and in preparing validation and operational documents
• Meeting targets, goals and schedule requirements
• Interfacing with co-workers and vendors
• Ability to make sound decisions and recommendations
• Ethics and professional integrity
• Overall contribution to success
• Accuracy, quality and speed of meeting expectations

The incumbent will be expected to interface effectively with all personnel associated in the effort to bring the product into production and will be expected to organize and lead small teams or groups in the attainment of goals and targets.

The incumbent will be able to take responsibility of several simultaneous projects and will also be required to interface with vendors in all phases of the process development.

The incumbent will be energetic, confident, capable and prepared to contribute to the enthusiasm and spirit of the company.

Qualifications