LanceSoft
Join our innovative team in Lafayette, CO, where scenic views meet cutting-edge technology. As part of the Airways R&D sustaining engineering group, you will support our range of disposable medical devices, ensuring they remain at the forefront of the market.
Responsibilities
Perform Design Verification Testing in a laboratory environment. Update product design documentation, including Design History Files, V&V testing reports and protocols, and Product Requirement Documents. Implement minor system and process changes to address quality issues. Design, develop, analyze, troubleshoot, and provide technical skills during research and/or product development. Lead and assist with issues relating to CAPAs, customer complaints, and manufacturing processes. Conduct failure investigation and root cause analysis. Support research on raw materials, components, and assemblies for MoC compliance. Generate Engineering Change Orders to support product sustaining efforts. Essential Functions
Provide technical support for existing products by developing solutions for moderately complex problems. Maintain product performance and quality for existing products. Support the implementation of eIFU's (Electronic IFU) Program. Adhere strictly to policies and procedures associated with an FDA-controlled environment. Minimum Requirements
Education:
BSME or BSEE or equivalent with manufacturing/mechanical experience and product life cycles.
Experience:
0-2 years of experience working in a multifaceted environment with internal and external customers in a technical support role.
Preferred Skills/Qualifications
Demonstrated experience and a proven track record of success in product support. Experience with internal and outsourced sustaining development projects. Proven ability to partner with cross-functional organizations to drive business success. Solid working knowledge of quality and regulatory requirements. Strong communication skills, both verbal and written, across various levels of the organization. Proficiency in CAD - Solidworks (3D models and 2D drawings). MS Teams proficiency and good documentation practices. Medical device and clinical environment experience. Skills/Competencies
Problem solving Priority setting Customer focus Driving for results
Join us at our Lafayette, CO campus, where you'll work a minimum of 4 days per week in a collaborative and dynamic environment. Embrace the opportunity to contribute to impactful projects while enjoying the vibrant community and stunning landscapes of Lafayette.
Responsibilities
Perform Design Verification Testing in a laboratory environment. Update product design documentation, including Design History Files, V&V testing reports and protocols, and Product Requirement Documents. Implement minor system and process changes to address quality issues. Design, develop, analyze, troubleshoot, and provide technical skills during research and/or product development. Lead and assist with issues relating to CAPAs, customer complaints, and manufacturing processes. Conduct failure investigation and root cause analysis. Support research on raw materials, components, and assemblies for MoC compliance. Generate Engineering Change Orders to support product sustaining efforts. Essential Functions
Provide technical support for existing products by developing solutions for moderately complex problems. Maintain product performance and quality for existing products. Support the implementation of eIFU's (Electronic IFU) Program. Adhere strictly to policies and procedures associated with an FDA-controlled environment. Minimum Requirements
Education:
BSME or BSEE or equivalent with manufacturing/mechanical experience and product life cycles.
Experience:
0-2 years of experience working in a multifaceted environment with internal and external customers in a technical support role.
Preferred Skills/Qualifications
Demonstrated experience and a proven track record of success in product support. Experience with internal and outsourced sustaining development projects. Proven ability to partner with cross-functional organizations to drive business success. Solid working knowledge of quality and regulatory requirements. Strong communication skills, both verbal and written, across various levels of the organization. Proficiency in CAD - Solidworks (3D models and 2D drawings). MS Teams proficiency and good documentation practices. Medical device and clinical environment experience. Skills/Competencies
Problem solving Priority setting Customer focus Driving for results
Join us at our Lafayette, CO campus, where you'll work a minimum of 4 days per week in a collaborative and dynamic environment. Embrace the opportunity to contribute to impactful projects while enjoying the vibrant community and stunning landscapes of Lafayette.