MicroPort CRM consists of three facilities: Saluggia (IT), Clamart (FR) and Santo Domingo (DR).

Within the Quality department- Centre of Excellence, you will report to Microbiology & Biocompatibiliy Manager.

The Microbiology and Biocompatibility Centre of Excellence is based in Saluggia, responsible to:

–       validate and maintain the sterilization validations of MicroPort CRM devices manufactured in Santo Domingo and Saluggia sites;

–       demonstrate and maintain devices biological safety;

–       guarantee the compliance of all MicroPort CRM clean rooms to the applicable standards;

–       participate to the ISO-Medtech groups for standards review;

–       be reference for the Company device materials definition and physical/chemical properties.

You will be part of a team with valuable competences and with a strong experience in the medical devices field. You will be involved in a wide spectrum of activities and you will have the opportunity to learn on the job and with specific trainings to cover your missing knowledge.

A team of enthusiastic, passionate and determined professionals is looking for you!

We will have the opportunity to growth together.

It is the responsibility of the Microbiology & Biocompatibility specialist in MicroPort CRM to manage sterilization and microbiological services for MicroPort CRM under the manager supervision and in collaboration with peers.

All the analysis are entrusted to external qualify Suppliers: the frequent and positive collaborations with external Laboratories is part of the daily job activities.

YOUR MISSIONS WILL BE AS FOLLOWS

·       validation of all the sterilization methods processes according to the applicable standards;

·       manage the routine sterilization process;

·       participate to the definition of device cleaning procedures;

·       review of all microbiological analysis on products/semiassemblies, components, supplies, etc. (e.g. sterility testing, bioburden, bacterial endotoxins) defining and managing when applicable testing to be performed, and validating new methods in collaboration with the external Laboratories, when required;

·       provide support in all Microbiology/Sterilization/Biocompatibility matters on the products business continuity (e.g: supplier/process changes);

·       participate to ensures that all processes under Microbiology and Biocompatibility function duties are compliant to QMS requirements and GMP;

·       frequent use and application of technical standards, engineering principles, theories, concepts, and techniques as well as statistical elements;

·       analyze processes data for trends and communicating to peers and management to identify issues and improvement opportunities;

·       participate to development, reviews and approval of quality system procedures, investigation (e.g. corrective and preventive actions) and audit responses;

·       develop and maintain effective relationships with internal personnel and external stakeholders to facilitate and drive the resolution of regulatory compliance and product quality issues;

·       Manage and document the department not conformances according to MicroPort CRM Quality System requirements, documenting appropriately the root cause analysis (according to adequate quality tools), and define and implement corrective actions and verifications.

As part of the COE group you will be involved in:

·       guarantee the compliance and monitoring of manufacturing areas to the applicable standards classification: routine environmental controls management/review, hygienic rules definition for personnel /environment and related trainings, cleaning solutions and cleaning program;

·       participate to the definition of the devices biological evaluation plan and report, as well as reviewing biocompatibility test reports and chemical characterization/toxicological assessments.

As part of the Quality Team:

·       participate to the CAPA system and subsystem by trends analysis, driving root cause analysis and risk management activities, as necessary;

·       assist on quality audits;

·       leads effective meetings, conducts presentations, keeps quality records, meeting minutes and action items including follow up.

🎓 IL TUO PROFILO

·       Scientific Master’s degree: Biology, Biotechnology, Chemistry, CTF etc.

·       Knowledge of the standards related to sterilization (mainly ISO 11135 and ISO 10993-7) and microbiology;

·       Excellent written and verbal communication skills. 

·       English advanced level is a must.

·       Proficient in MS Office including Word, Power Point, and Excel.

·       Strong interpersonal skills.

·       Attention to details, sense of responsibility.

·       Attitude to the use and application of technical standards, engineering principles, theories, concepts, and techniques as well as statistical elements.

·       Ability in issuing validation protocol/reports, data trend, technical rational, assessments etc.

·       At least two years of experience in the sterilization validation department of a biomedical company; experiences in another highly regulated environment can be considered as well. Higher experience may be considered for a senior role with less supervision

·       Problem Solving: provides technical solutions to a wide range of difficult problems.  Solutions are imaginative, practicable and consistent with organization objectives and applicable standards.

·       Latitude: works under manager supervision. Follows established procedures. Work is reviewed for soundness of technical judgment and overall adequacy. Contributes to the completion of specific programs and projects.  Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

·       Interaction: Frequent inter-organizational and outside customer contacts.

💰 COSA OFFRIAMO

Naturalmente, ci sono compensi, vari benefici, opportunità di carriera e tutto il pacchetto che di solito si trova in un’azienda. Ciò che conta davvero alla fine è il motivo per cui veniamo a lavorare ogni giorno e che quello che facciamo fa davvero la differenza. A differenza di posizioni simili in aziende più grandi, avrai l’opportunità unica di lavorare in un’organizzazione a misura d’uomo ma internazionale e sostenere prodotti salvavita in tutto il mondo.

Se hai “occhi per la grandezza, mani sui dettagli”, allora puoi fare la differenza nella nostra azienda! Ognuno di noi in Microport CRM è qui per aiutare le persone a vivere una vita più lunga e più sana, non importa quale sia la nostra competenza.

LA NOSTRA OPPORTUNITA’

Our mission is to strive to create high-tech implantable devices and diagnostic solutions for cardiac diseases, which are accessible to the greatest number of people, while offering valuable services to patients, physicians, hospitals and health care insurers.

The Electronic Engineer in Saluggia, under the Global Operations Department, is the plant technical reference for internal and external customer on electronic arguments.

As an Electronic Engineer he/she will develop and test components, devices, systems or equipment that use electricity as part of their source of power. These components include capacitors, diodes, resistors and transistors.

We are looking for you, as Electronic Engineer: you will ensure the management and maintenance of electrical test benches installed in Saluggia plant and you will be the link with R&D team based in our European HQ (Clamart- France). Following the synergy strategy between plants, you will also support Clamart team directly on their plant in case of need.

As for us the patient always comes first, we strive daily to deliver medical devices for heart related conditions that help people live longer and healthier lives.

Your mission will be as follows:

– Develop, validate and supervise manufacturing processes (electrical/software/IO data) to assure high standard in term of quality and industrial performances
– Accountable and Responsible for Installation (including maintenance and calibration), supervise and optimize electrical test benches performances in order to improve quality standard and reduce industrial costs
– Responsible for test benches defect failure analysis/Product Expertise leading activities, involving R&D test bench team, to final solution implementation
– Responsible to identify technological automation bricks, equipment/test bench and tools requirements necessary to optimize manufacturing efficiency while improving quality, identifying final solution and validating its intended use
– Responsible for scheduled or extraordinary maintenance and calibration on electrical test benches
– Support operators in the management of equipment
– Accountable for change management implementation
– Responsible of ESD compliance and internal rules identification and deployment

Your profile:

– Knowledge in the electronic and electrical matters (Signal theory, Electrical communications via cable and conveyed waves, – – – – Electronics applied to components and circuits)Ability to read electrical schemes drawing
– Ability to read electrical schemes drawing
– Good knowledge of tools for troubleshooting (oscilloscope, digital multimeter, soldering iron)
– Project Management
– Knowledge of PLC programming (nice to have)
– Critical approach
– Self-Time Management
– Interpersonal skills and aptitude for team work
– Spirit of initiative
– Use of informatics tool (Office pack)
– Fluent English language
– French language is a plus
– Master Degree in Electronic, Electric, Telecommunication Engineering
– Experience of at least 3 years as Electronic Process Engineer or Electronic R&D Engineer

What we offer:

Of course, there are compensation, various benefits, career opportunities and the whole package you usually find in a company. What really matters in the end is why we come to work every day and that what we do really makes a difference.

Unlike similar positions in larger companies, you will get the unique opportunity to work in a human scale yet international organization and support life-saving products all over the world.

If you have “eyes for greatness, hands on details”, then you can make a difference inside our company! Each of us at Microport CRM is here to help people live longer and healthier.

LA NOSTRA OPPORTUNITA’

Our mission is to strive to create high-tech implantable devices and diagnostic solutions for cardiac diseases, which are accessible to the greatest number of people, while offering valuable services to patients, physicians, hospitals and health care insurers.
We are looking for you, as a Product Specialist- Intern, you will operate in Sales Department covering a fundamental technical role: the main purpose is to provide technical assistance for implant of CRM products (PM, ICD and CRT) and support physicians during devices follow-up.

Your missions will be as follows:

Technical support in the surgery room during Defibrillators and Pacemakers implants
Technical support for ICD and PM follow-up
Emergency interventions for any technical problems
Product presentations (for customers and for Sales team)
Updating of programming systems
Participation in congresses and meetings to support marketing colleagues, while building relationships with customers
Keeping technical trainings for physicians and nurses

Your profile:

Good public speaking skills
Willingness to travel (driving license is mandatory)
Graduation in tech field (graduation in technical subjects, Biomedical Engineering is preferential)
Good knowledge of English

What we offer
Of course, there are compensation, various benefits, career opportunities and the whole package you usually find in a company. What really matters in the end is why we come to work every day and that what we do really makes a difference.
Unlike similar positions in larger companies, you will get the unique opportunity to work in a human scale yet international organization and support life-saving products all over the world.
If you have “eyes for greatness, hands on details”, then you can make a difference inside our company! Each of us at MicroPort CRM is here to help people live longer and healthier lives no matter which is our expertise.

Position summary
This position supports the development, manufacturing, release and post market surveillance activities associated with MicroPort CRM products.
Ensures the maintenance of quality KPI.
Provides promptly support to Operations and enhance system efficiency to guarantee the achievement of the business goals.
Provides technical guidance to all pears on best practices and regulatory requirement.

Essential job functions

• Manage autonomously non conformities and CAPA related to product and processes
• Develop, reviews and approves quality system procedures
• Complete root cause investigation and corrective actions related to complaints
• Actively participates to internal/external Audits
• Analysis of trends
• Leads and participate to projects (cost reduction and compliance) providing clear direction to other departments of product Quality and design testing requirements
• Lead the creation and maintenance of device Risk Management at all stages of the design process and review final technical responses and/or failure investigation reports.
• Lead the creation and maintenance of device Human Factor Engineering Protocols and

Reports

• Prepare and/or participate to Design Verification and Shelf-life Protocols and Reports to challenge new products and product development/modifications.
• Maintain up-to-date knowledge of technology development for relevant projects and relative applicable standards.
• Collaborate in the development of new test methods as appropriate for evaluations of product characteristics.
• Lead the Validation of the test methods to ensure they are accurate, reliable and repeatable.
• Lead and drive the process validation strategy for new products to minimized product risks.
• Manage all the Quality related activities to give desired project outcomes in terms of quality and meeting deadlines.
• Actively drive continuous improvement of Quality/design review and ensure compliance to existing specifications.- exceeds expectation
• Frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
• Works under general supervision. Follows established procedures. Work is reviewed for soundness of technical judgment and overall adequacy.

Knowledge, skills and abilities required

• Black belt Six Sigma certification
• PMP Certification
• Certified ISO 13485:2016 auditor
• Proficiency in the problem solving techniques
• Proficiency in the application of risk management tools
• Good knowledge in the application of statistical techniques
• Proficiency in coaching and influencing techniques
• Proficiency in English oral and written
• Proficiency in MS office word, excel and power point.
• Excellent written and oral communication
• Proficiency in calibration

Education
Master Science in Biomedical or Mechanical Engineering.

Experience
At least 3 years of experience in Quality on a medical device company and/or GMP ruled company