Validation Design Engineer

A multidisciplinary U.S.-based firm, our team bridges mechanical, electrical, and biomedical disciplines to accelerate product approval cycles. We partner with Fortune-500 manufacturers as well as venture-backed startups, supplying evidence that devices perform flawlessly under real-world stressors—vibration, thermal shock, fluid ingress, and fatigue. Our labs house environmental chambers, servo-hydraulic rigs, and high-speed vision systems, yet we embrace virtual collaboration. You will interface with design, quality, and manufacturing stakeholders scattered across multiple time zones while preserving a healthy work-life cadence.

Responsibilities  

- Develop comprehensive Design Verification & Validation Plans and Reports (DVPR) that satisfy FDA 21 CFR 820, ISO 13485, IATF 16949 requirements.  

- Model and document bespoke mechanical or electro-mechanical test fixtures in CAD, ensuring repeatability and operator safety.  

- Program automated test sequences in LabVIEW and integrate DAQ hardware for high-resolution data capture.  

- Execute verification protocols, collect data, and apply Design of Experiments (DoE) to optimize key parameters.  

- Lead root-cause investigations using 5-Why, Ishikawa, and fault-tree techniques; drive durable corrective actions.  

- Compile concise technical reports with statistical analysis (Minitab, JMP) for regulatory and executive audiences.  

- Embed V&V best practices throughout the product life-cycle by partnering with R&D, quality, and manufacturing teams.  

- Mentor junior engineers and technicians in measurement-system analysis, Gage R&R, and fixture maintenance.  

Required Qualifications  

- Bachelor’s degree in Mechanical, Electrical, Biomedical, or Aerospace Engineering.  

- 5+ years in validation, verification, or test engineering within highly regulated industries.  

- Documented ownership of DVPRs from concept through submission.  

- Hands-on proficiency with LabVIEW, DAQ systems, and Minitab or JMP.  

- Advanced CAD skills (SolidWorks or Creo) for fixture design.  

- Demonstrated expertise in DoE, statistical tolerance analysis, and Gage R&R.  

- Deep knowledge of FDA QSR, ISO 13485, and ISO 9001 standards.  

- Fluent technical writing that withstands regulatory scrutiny.  

Preferred Skills  

- Experience with lithium-ion battery, robotics, or implantable devices.  

- Familiarity with IEC 60601, MIL-STD-810, or AS9100 test regimes.  

- Exposure to automated vision systems and PLC-based test stands.  

- Lean Six Sigma Green Belt or higher.  

- Ability to travel occasionally to domestic labs (<10 %).