Cale Mcculloch Email & Phone Number

Lemon Grove, Ca, Us

Lemon Grove, Ca, Us

San Diego, California, Us

Cary, North Carolina, Us

- Lead Quality Engineer responsible for reviewing and approving engineering drawings, material specs, change orders, and design control documentation for various medical device clients.- Performed design controls (risk analysis/assessment, product requirements, requirement traceability matrix) prior to design verification for a novel digital visualization headset intended for operating room and dental procedures.- Improved SCAR procedure to reduce the workflow burden on suppliers and achieve timely supplier corrective action.

Toronto, Ontario, Ca

- Lead Quality Engineer responsible for initiating, reviewing, and approving designs, drawings, & documents on change orders for the instruments subsystem of the ENOS surgical single-port robotic system during design & transfer to manufacturing.- Core team member for Design Reviews with responsibilities including review and approve design and transfer to manufacturing deliverables to ensure technical robustness and regulatory compliance.- Created and released improved various local Quality Management System (QMS) manufacturing procedures, work instructions, and templates related to Receiving, Receiving Inspection, and Equipment Management and Validation.- Hired and managed QC Inspector to inspect and approve/quarantine received ENOS Instruments components for verification build.- Initiated, reviewed, and completed nonconformance investigations, and implemented corrections and dispositions.- Authored, reviewed, and approved various manufacturing equipment validation protocols and reports.- Determine supplier approval levels & review objective evidence to approve suppliers.- Communicate with suppliers to investigate supplier-related nonconformances and implement corrections.

Abbott Park, Illinois, Us

- Responsible for ensuring on-market design changes and new eReader+ Drug Screening System product release comply with QMS design controls and FDA and international regulatory standards.- Created and released a QC inspection procedure for newly released eReader+ Drug Screening Instrument, which identified and contained several defects from the contract manufacturer and supplier prior to product distribution. - Hired and managed a team of the Quality Control inspectors overseeing the newly deployed incoming inspection process of the eReader+ Drug Screening Instrument for 4 months.- Completed quality incident (non-conformance) investigations, and implemented corrective and preventive action (CAPA) and supplier corrective action where necessary.- Developed, reviewed, deployed, and improved various cross-site Quality Management System (QMS) procedures and work instructions, including quality control and complaint returns.- Reviewed, analyzed and provided recommendations for verification and validation test data, and provided guidance on resolving any deviations associated with verification and validation activities.- Authored, reviewed, and approved Installation, Operation, and Process Qualification and process validation protocols and reports, assuring alignment with the quality management system.- Communicate with suppliers to investigate supplier-related quality incidents and ensure corrective action and SCARs are prioritized and completed timely.- Quality Assurance Core Team member for Design Reviews with responsibilities including review and approve design & development deliverables to ensure technical robustness and regulatory compliance.

Franklin Lakes, New Jersey, Us

- Responsible for ensuring design changes and new product releases comply with QMS design controls and FDA/ international regulatory standards, and measurably improve customer experience for the Alaris System infusion platform.- Communicate with suppliers to ensure component specifications, process capability metrics, and control targets are met.- Execute FMEAs, plan V&V/reliability test strategy, and perform statistical t-tests, sample size calculations and rationale.- Lead quality engineer on release of enhanced IV pole clamp design of on-market Alaris PCU, which reduced install time by 4 seconds in time-sensitive healthcare environments while maintaining equivalence in clamping performance.Lead quality engineer on key quality improvement projects for Alaris PCU, which resolved mechanical out-of-box failures and improved mechanical reliability under operating environment extremes, and resolved missed alarms through a software patch to improve customer experience.- Provide quality engineering support in Fault Tree Analysis (FTA), durability & reliability test planning, and data analysis for next-gen infusion pump platform.

Franklin Lakes, New Jersey, Us

- Provided cross-functional mechanical engineering support for quality improvement projects to improve product robustness, customer experience, and reduce risks in infusion therapy while adhering to FDA design controls.- Planned and executed injection molding tooling validations, DOEs, design verification tests, production change orders, design reviews, failure investigations for the Alaris System and Asena System over 4+ years.- Designed and analyzed eight potential design solutions for an infusion pumping mechanism cover to improve fluid seal.- Designed and qualified two unique life cycle fixtures for design verification reliability testing the Alaris LVP/CC pumps.

Franklin Lakes, New Jersey, Us

- Provided cross-functional mechanical engineering support for quality improvement projects to improve product robustness, customer experience, and reduce risks in infusion therapy while adhering to FDA design controls.- Planned and executed regulatory compliance testing under CSA review for IEC 60601-1 3rd Edition compliance.- Investigated source of fluid ingress observed on the Alaris LVP through isolated enclosure seal testing, and led resulting design change CAPA project to improve fluid ingress resistance for identified entry paths. - Investigated and identified root cause of high-frequency stress fractures on a critical component of on-market Alaris LVP and supported qualification of the design change for improved chemical resistance from the resulting CAPA.

Yucaipa, Ca, Us

- Established a tooling outsourcing project to save tool grinding man-hours on long-running jobs.- Updated and documented around 150 tooling drawing revisions.- Implemented a spare tooling plan for tooling grinders that prioritized current jobs and reduced machine downtime. - Shadowed a tool design engineer and acquired knowledge in cutting tool design and low tolerance grinding.

- Organized several company tours for ASME members, conducted club meetings, and designed annual club t-shirts.- Assisted in the planning and execution of ASME projects and activities, negotiated with other club officers. - ASME at UCR received the annual Professional Development Award amongst 22 other student organizations.

- Supervised a small group of first and second-year students. Met with students monthly and advised them in both college and career success.- Offered assistance with relevant coursework and comprehension covering thermodynamics, dynamics, statics, etc.- Gained experience in aiding fellow colleagues in both education and professional development.

- Completed a Machine Shop 101 class at Vocademy, Inc.- 50+ hour instructional class featuring practical knowledge on common materials and hardware, hands-on experience with various machines including mills and lathes. - The course emphasized improving technical skills and knowledge in design for manufacturing.

Bachelor Of Science (B.S.), Mechanical Engineering

Education record