Engineer II – 2 positions
Location: Colorado Springs CO
Duration: 9-10 months (extendable)
• With minimal supervision, develop SolidWorks drawings/models of medical device production equipment that include all material specifications, critical and noncritical dimensions and parts lists as required by the QSR and ISO guidelines.
• Create and or edit medical device manufacturing equipment specifications and installation qualifications protocols by evaluating manufacturing operations and risk assessment documents.
• Validate existing preventive maintenance documents are adequate and update as necessary.
• Execute full installation qualifications for all existing production equipment and document report in change management system.
• Create or edit part folder structure to ensure alignment with current quality system requirements.
Key Duties and Responsibilities:
• Create CAD models for manufacturing equipment that specify all dimensions, materials, and parts required to meet the function of the tool. The drawings should provide adequate detail to ensure a machine shop could fabricate the customized parts.
• Develop a functional understand of all manufacturing equipment through direct observation or evaluation of operation SOP’s to determine critical equipment functions.
• Create technical documents and utilize the Agile change management system to gain customer approval of proposed changes to existing or new documents.
• Act as subject matter expert (SME) regarding equipment preventive maintenance requirements.
• Partner with manufacturing engineerings to validate existing procedures are adequate or update procedures as needed.
• Partner with maintenance technicians to properly document all requirements of the preventive maintenance SOP template.
• Develop an understanding of the corrective maintenance history for each production machine to develop effective preventive maintenance standards and spare parts lists.
• Research suppliers for spare parts and document the required purchasing information.
• Develop an understanding of each production machine’s function and its impact on the product and ultimately the patient to develop a risk profile for each fixture.
• Determine machine part dimensional tolerances based on its function and risk profile.
• Execute the installation qualification for all existing machines. Document each qualification on the appropriate report and submit report in Agile for approval.
Supervisory Duties: None
Material and Equipment Directly Used:
• General measuring equipment such as calipers, micrometers, and tensile test equipment.
• Applicable production machines.
• Applicable software packages – SolidWorks & Agile document control experience preferred.
• Appropriate tools, as necessary.
• BS Degree or equivalent work experience
• 5-10 years experience working within engineering or technical project team environments.
• 10+ years working within technology fields involving electro-mechanical equipment, automation, and lean production processes.
• Excellent electrical and mechanical troubleshooting skill sets including conceptual design awareness and hands-on practical knowledge.
• Ability to work independently, with a proactive sense of urgency.
• Direct experience working within FDA CFR 21 820 controlled environments.
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