Senior Sustaining Engineer - Consumables
This engineering role supports Cytovale’s consumables roadmap and project execution in the back-end of the design process: production, scale up, and sustaining. Cytovale’s consumables include: bottled sample preparation reagents, bottled blood-based control samples, a test-specific single-use cartridge comprising an inertial microfluidics chip assembled into an injection molded body, and all related packaging and labeling.
This role will help prioritize and complete investigations and product changes involving the consumables. The ideal person for this role has interest in becoming the technical design & documentation owner for assigned consumable products. They should be a self-starter who wants to work as an individual contributor to complete required tasks, but also be willing to organize/manage cross-functional groups to ensure required activities are completed.
- Participate in consumables-related complaints, manufacturing trending, and technical issue escalation.
- Perform initial product risk assessments and scoping of potential improvements/actions.
- Organize and influence prioritization of consumables sustaining initiatives; help track progress.
- Lead or support design changes, investigation, improvements, and the like, including:
- Complete and/or review quality records (e.g. NCR, Deviation, SCAR, CAPA, complaints)
- Determine and implement design and/or documentation updates, via a controlled change process
- Plan and complete required testing, including selecting and applying appropriate statistics
- Perform document impact assessments and upkeep of the product DHF (e.g., requirements, risk, V&V, traceability)
- Perform design/manufacturing impact assessments and upkeep of the product DMR (e.g., drawings, specifications, BOMs, mfg incorporation).
- Develop and maintain test tools/fixtures, including test method and tool validation.
- Perform role function in compliance with Cytovale’s QMS.
- Other duties as assigned.
- Bachelor's degree in Mechanical or Biomedical Engineering, or similar, with 5+ years of relevant medical device industry experience.
- Experience with plastic consumables/disposables medical device products required; experience with reagents, labels, packaging, or IVD/related equipment preferred.
- Experience creating/maintaining/updating DHF and DMR documents, and contributing to quality records required. Experience with change control / complaints preferred.
- Strong organizational / project management skills and attention to detail.
- Knowledge of regulatory standards such as CFR 820, ISO 14971, ISO 13485, IEC 62304
- CAD/drawing experience preferred.
- A strong desire to work in a small, fast-paced environment of a late-stage startup.
- Ability to work in the United States.
- This position is based in San Francisco.
- Role is 3 days per week onsite, and as-needed to carry out role functions.
- Some travel may be required (up to 10%).
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