Test and Verification Consultant [F/M/X]

Permanent Job

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.

• 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; elevate blockers within 24 h.

• 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.
• 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.

Amaris Consulting is proud to be an equal‑opportunity workplace. We welcome applications from all qualified candidates, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.