Drafting Quality Engineer

SaniSure LLC•Camarillo, CA

About The Position

SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today's most innovative and life-changing medicines. As we continue to expand our product offerings and global footprint, SaniSure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry. The Drafting Quality Engineer reviews 2D engineering drawings prior to release to production to catch drawing errors before they enter production. This role strengthens drafting practices, improves production flow by reducing holds needed to correct errors, and increases end-customer confidence by reducing post-release change approvals.

Requirements

Experience reading and reviewing mechanical/engineering 2D drawings.
Familiarity with ERP systems (SyteLine or similar) and PDF markup tools (Adobe PDF).
Strong understanding of complex design tolerance stack-up and process optimization principles.
Proficient in SolidWorks, with experience managing large assemblies and transitioning teams to integrated workflows.
Strong attention to detail and organizational skills for error tracking and documentation.
Strong ownership of design best practices and a drive to continuously improve development standards and workflows.
Ability to work cross-functionally with drafting, manufacturing, and product engineering teams.

Nice To Haves

Experience developing products for bioprocessing, medical device, or other highly regulated manufacturing environments.
Familiarity with single-use system design, including tubing, bag, and fitting integration.
Knowledge of ISO 13485, ASME BPE, or related design standards.
Working knowledge of PLM and ERP systems such as QT9, SAP, or similar platforms.
Prior experience establishing design guidelines or contributing to company-wide engineering standards.

Responsibilities

Review 2D engineering drawings prior to release to production, marking up errors and inconsistencies in Adobe PDF.
Confirm there is a customer-signed copy of the drawing.
Verify the units of the drawing match the template.
Confirm the description of the part matches the part number.
Confirm none of the components are obsolete.
Check quantities on the Material List Table match what is shown on the drawing.
Review balloon callouts for missing or incorrect callouts.
Verify material callout in the Material List Table has at least 1x callout.
Confirm component matches description in the Material List.
Check engagement of Barb OD to Tube ID – verify there is a slight interference.
Check engagement of Tube OD to Fastener; confirm zip tie or Oetiker is sized appropriately.
Check material compatibility: "Attached" components should generally match the base material. Confirm functional combination of Cap to Bottle. Verify accuracy of material callouts.
Check written notes: Notes must include actual dimensions, not descriptive references such as "Tube to end of bottle." Ensure notes are appropriate for the size of the system.
Confirm all features are accounted for, with no missing dimensions.
Identify manufacturing-only dimensions that do not impact form/fit/function to the customer and can be converted to reference only or given larger tolerances.
Flag drawings with swapable valves for confirmation by the manufacturing team.
Maintain a log of drawing errors identified, rationale for corrections, and action plan and next steps for correction, and confirm duplicates are not being re-checked.
Communicate review findings and status to the internal stakeholders on a regular cadence.
Recommend improvements to drafting practices to reduce recurring issues.
Provide ongoing support in refining SaniSure's drafting checklist and standards.
Perform additional job duties as assigned.