R&d Mdr Specialist

3 settimane fa

Sesto San Giovanni, Italia amaris A tempo pieno

Job description

Join the Amaris Consulting talent network as an R&D MDR Specialist in the Biomedical industry in Milan

What will you do?

Development of individual project deliverables as part of the overall program deliverables.
Lead the specification design phases of the product and the technical team in development phases.
Manage day-to-day technical challenges and communicate any risks or issues associated with development activities to the project manager.
Collaborate cross-functionally with Quality, Manufacturing, and Sourcing, leading R&D activities/projects.
Design components and finished products, with expertise in plastics material and process techniques.
Support and manage the creation of drawings and bill of materials for components and finished products.
Define and implement functional physical tests for products under development.
Prepare product design documentation, including design input, design specifications, and design transfer.
Responsible for risk analysis activities, including health hazard assessment, Fault Tree Analysis, Process Failure Mode Control Analysis, Design Failure Mode Control Analysis, Design of Experiments, Statistical Process Control, Process Capability, and Sampling Techniques.
Navigate complex regulations, including FDA QSR, ISO13485, ISO 8637-1, ISO14971, EU Medical Device Directive, Eu.Pharmacopoeia, and ICH.

✍️ What do we request?

Master's degree in Biomedical, Mechanical Engineering, or a relevant discipline.
At least 2 years of relevant experience in a related position.
Product Life Cycle system and Design Control knowledge.
Experience in Biomedical regulation or product development within a biomedical environment.
Team-working attitude, Project Leading and project management skills.
Excellent command of Italian and English.
Knowledge of medical devices/materials and/or a pharma background.

✨ What do we offer?

Work by objectives with quarterly monitoring.
Educational and technical growth path.
Inclusive work climate.
Lunch vouchers of €8 per working day.
Free access to Mantu Academy platform with more than 500 courses.
Free access to Udemy platform with more than 200,000 courses.
Psychological counseling.

**Pioneer Spirit**: a desire to explore new technologies, ideas, and skills to build a more sustainable world.

**Care**: a commitment to promoting diversity, meritocracy, and environmental protection for a better future.

**Performance**: a constant ambition to achieve excellence through creativity, innovation, and technology.

**Trust**: trust is a pillar of progress, driving freedom, creativity, and innovation.

**Independence**: independence is the basis for realizing a prosperous and agile future.

Amaris Consulting is an industry-leading Top Employer 2023-certified company that supports its cross-sectors partners in the Biomedical sector.

We develop engineering activities in the areas of Development & Design, Testing & Validation, System engineering, R&D, and Project Management.

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 6000 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.

**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.

We look forward to meeting you

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