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.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this reason, we welcome applications from all qualified candidates, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!