Jobid=da708639e0ea (0.102)
Job description
Are you a verification leader who thrives on turning complex hardware requirements into bullet-proof, regulation-ready evidence? Join Amaris Consulting as a Test and Verification Consultant and own the verification strategy behind next-generation medical and high-reliability devices at our clients.
This is more than a senior engineering role—it is your platform to shape verification processes, mentor future experts, and safeguard products that improve and save lives.
Your Impact: What You’ll Do
- Define and own the global hardware verification strategy, ensuring 100 % requirement coverage (70 % regulated medical devices, 30 % non-medical).
- Author, review, and approve master test plans, protocols, and reports that satisfy FDA 21 CFR Part 820, ISO 13485, IEC 60601, and ISO 17025.
- Lead verification work packages: decompose deliverables, assign ownership, and track execution across multidisciplinary teams.
- Detect, log, and drive closure of all design defects; perform root-cause analysis and implement corrective/preventive actions (CAPA).
- Build and maintain the integrated verification schedule; recover slippage without compromising quality or compliance.
- Guarantee audit-ready verification evidence—zero findings during internal and external inspections.
- Chair design-review checkpoints and risk-assessment sessions; sign off only when residual risk is as low as reasonably practicable.
- Continuously optimize test processes to cut cycle time ≥15 % and raise defect-escape detection rates.
- Establish and scale a worldwide T&V knowledge-sharing network; standardize best-practice templates and lessons learned.
- Mentor 5–10 verification engineers on test-method design, equipment qualification, and regulatory interpretation; deliver formal training sessions.
- Manage test-equipment lifecycle: specify, validate, calibrate, and maintain all rigs and fixtures.
- Communicate status, risks, and decisions to project managers, QA, RA, and development leads; escalate blockers within 24 h.
Who You Are: Key Qualifications
- Master’s or Bachelor’s in Electrical Engineering, Mechatronics, Physics, or a related technical field.
- 3 + years hands-on hardware design verification in FDA- or CE-regulated products (medical devices strongly preferred).
- 5 + years R&D or research-laboratory background.
- 5 + years total professional experience in a regulated industry (medical, aerospace, automotive, or similar).
- Expert in hardware testing methodologies, statistical analysis (MSA, Gage R&R, DOE), and reliability engineering.
- Proven author of Design Verification & Validation plans that satisfy FDA 21 CFR Part 820 and ISO 13485.
- Deep knowledge of IEC 60601, IEC 62304, ISO 14971, ISO 17025, and harmonized standards.
- Solid command of Design Controls: user needs → design inputs → outputs → verification → validation → risk file traceability.
- Proficient in test-method development, validation, and sample-size justification using statistical techniques.
- Demonstrated ability to lead technical teams of 5–10 engineers and manage multiple concurrent projects to aggressive timelines.
- Advanced user of Windchill PLM (or equivalent) for requirements and traceability matrices.
- Expert with Minitab (or similar) for statistical analysis, capability studies, and test-method validation.
- Excellent written and verbal communication—produce audit-ready documentation and present to stakeholders at all levels.
- Strong analytical mindset: dissect data sets, identify root causes, and convert insights into measurable process improvements.
- High sense of ownership, self-driven, fast learner, and comfortable working in a matrix organization.
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