Job description
As a Senior Consultant, you will be embedded in a high‑tech innovation environment, supporting product safety and risk management across new product introductions, sustaining engineering, and post-market surveillance.
Responsibilities
- Lead product safety and risk management activities across the full product lifecycle, from new product introduction through sustaining engineering and post-market surveillance.
- Own safety-risk deliverables from initial assessment to approval and closure, balancing technical quality, regulatory compliance, audit readiness, and deadlines.
- Drive CAPA investigations by defining hazardous situations, linking failure modes to potential harm, assessing severity and occurrence, and documenting root causes.
- Author and review post-market risk reviews, safety rationales, risk assessments, and supporting records for investigations, field actions, and complaint-trending decisions.
- Translate complaint data, system logs, installed-base information, and replacement rates into clear risk assessments and recommended actions.
- Coordinate corrective and preventive actions with R&D, Quality, Service, Regulatory, Medical, and Post-Market Surveillance teams.
- Monitor action plans, implementation risks, effectiveness checks, and closure activities, escalating issues when delivery or safety may be affected.
- Produce status reports, trend analyses, and performance metrics for management and governance forums, while coaching authors, reviewers, and engineering teams on risk-management practices.
Skills & Experience
- Master’s degree in Mechanical, Electrical, Software, Systems Engineering, or a related discipline; a PhD is a plus.
- 5+ years of experience in systems engineering, product safety, risk management, or a related role within the regulated medical-device sector.
- Strong knowledge of ISO 14971, ISO 13485, IEC 62366, FDA QSR/QMSR, and post-market surveillance requirements.
- Experience supporting CAPA investigations, field actions, complaint reviews, and product-safety assessments.
- Hands-on knowledge of structured problem-solving methods, including FMEA, FTA, 5 Whys, Fishbone analysis, and root-cause investigation.
- Ability to analyse complex, multidisciplinary systems and understand dependencies between hardware, software, users, and clinical workflows.
- Experience using complaint data, system logs, installed-base data, replacement rates, and other operational information to support risk-based decisions.
- Strong project-management skills, with a record of delivering complex technical and compliance-related activities through to closure.
- Excellent technical writing skills, with experience producing clear risk assessments, safety rationales, investigation reports, procedures, and audit-ready documentation.
- Familiarity with CAPA, change-control, risk-management, and quality-management systems, plus experience supporting audits by regulatory authorities or notified bodies.
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, part of Mantu is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 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!