Work with us

Recognized all over the world, Ente Certificazione Macchine is a market leader because we put 100% of passion, commitment and innovation in everything we do. ECM is a company founded on work and skills, which is why our staff represents the driving force behind the company’s success.

The ability to hire and grow talent is a fundamental goal for us.

We encourage new ideas and welcome people who stimulate the way we do. Through our diversified and international business, you can learn about and increase ECM’s know-how, helping to transmit our values ​​and at the same time achieve personal and shared goals.

If you want to get in touch with our reality, apply for one of the Open Positions or send us your Curriculum Vitae.

Application form

Open Positions

Ad title Place of work Job type Type of contract Publication date Job position description Apply
Lead Auditor Medical Devices (ISO 13485:2016 & MDR 2017/745) da remoto Full Time to be defined 06/05/2022 Read detail

Lead Auditor Medical Devices (ISO 13485:2016 & MDR 2017/745)

Ente Certificazione Macchine Machine Certification Body is looking for no.1 Lead Auditor to join its team of the Medical Devices Division. The resource will be responsible for:

–  Plan and conduct audits at client companies, in order to assess the compliance of the management system with the relevant requirements;

–  Prepare assessment reports and manage follow-up activities.

 

REQUIREMENTS

–  University degree or postgraduate qualification in disciplines related to the medical field, such as biomedical engineering, biotechnology or equivalent;

–  Professional knowledge of the English language (minimum level B1);

–  Knowledge of management systems, standards and regulations for the medical device sector;

–  Availability for national and international travel;

–  Preferred previous work experience in similar roles.

 

WORKPLACE

Work may be carried out remotely or at the ECM premises in Valsamoggia (BO), Italy.

 

The job offers is addressed to candidates of both sexes.

Lead Auditor Medical Devices (ISO 13485:2016 & MDR 2017/745)

Quality Assurance Specialist Valsamoggia, BO - Italia Full Time to be defined 28/04/2022 Read detail

Quality Assurance Specialist

Ente Certificazione Macchine – Notified Body no. 1282 and accredited Test Laboratory no. 1515L, recruits a Quality Assurance Specialist for its headquarters, who will be in charge of:

  • Management and maintenance of the company Quality System,
  • Relationship with inspection bodies,
  • Internal and external audit activities.

 

REQUIREMENTS

  • Engineering degree or relevant technical/scientific diploma
  • Excellent knowledge of the English language (minimum level B1)
  • Previous experience in the role of QA in the medical devices sector

 

KNOWLEDGE AND SKILLS

  • Knowledge of ISO 13485 requirements
  • Accuracy, excellent organisation and planning skills
  • Good interpersonal skills and team-working.

 

WORKPLACE

The work activity will be carried out onsite at the ECM premises in Valsamoggia (BO), with the possibility of smartworking.

 

The job offers is addressed to candidates of both sexes.

Quality Assurance Specialist

Clinical Expert Medical Device Regulation 2017/745 da remoto o in sede Full Time to be defined 08/04/2022 Read detail

Clinical Expert Medical Device Regulation 2017/745

JOB DESCRIPTION

ECM – Medical Devices Division is looking for a clinical expert who will be in charge of:

  • carrying out clinical data evaluations, in order to verify that medical devices meet the safety and performance requirements of the MDR Regulation 2017/745;
  • drafting of clinical evaluation reports (CEAR).

 

REQUIRED QUALIFICATIONS

  • University degree in Medicine or Surgery;
  • Excellent knowledge of the English language (minimum level B1).

 

REQUIRED EXPERIENCE

  • Clinical care activities;
  • Research activity in clinical sector, with experience in conducting or monitoring clinical investigations/trials or evaluating clinical data;
  • Publication of scientific articles.

 

COMPETENCES ACQUIRED

  • Knowledge and application of research methodology;
  • Thorough understanding of the design and development of clinical investigations;
  • Knowledge of the basic principles of medical statistics and clinical data evaluation;
  • Scientific data management (experience with relevant databases such as Embase and Medline).

 

WORKPLACE

The work activity could be carried out remotely or at the ECM office in Valsamoggia (BO), Italy.

 

The job offers is addressed to candidates of both sexes.

Clinical Expert Medical Device Regulation 2017/745

Technical Specialist & Scheme Manager – In Vitro Diagnostic Medical Devices (IVDs) da remoto o in sede Tempo Pieno da definire 25/03/2022 Read detail

Technical Specialist & Scheme Manager – In Vitro Diagnostic Medical Devices (IVDs)

With the aim of expanding its scope in the medical devices sector, Ente Certificazione Macchine – Notified Body no. 1282 – is looking for a figure with experience in the field of IVD devices.

 

JOB DESCRIPTION

The ideal candidate has gained solid experience in the field of In Vitro Diagnostic Medical Devices (IVD) and will be responsible for certification procedures according to Regulation (EU) 2017/746 (IVDR).

Among the activities that will be carried out:

  • management of certification activities for a broad international portfolio of IVD devices manufacturers;
  • evaluation of technical and clinical documentation of IVD devices to assess their compliance with Regulation (EU) 2017/746;
  • evaluation of the Quality Management System requirements according to ISO 13485 standard.

 

REQUIRED QUALIFICATIONS

  • Long-term experience in design, development, manufacturing or testing of IVD devices;
  • University degree or post-graduate degree in medical disciplines such as biomedical engineering, biology, biotechnology or equivalent;
  • Excellent knowledge of the English language (minimum B1 level skills);
  • Availability for occasional national and international travel.

 

WORKPLACE

The work activity could be carried out remotely based within the European Union, or at the ECM office in Valsamoggia (BO), Italy.

 

The job offers is addressed to candidates of both sexes.

Technical Specialist & Scheme Manager – In Vitro Diagnostic Medical Devices (IVDs)

Medical Devices Technical Expert - Orthopaedic da remoto o in sede Tempo Pieno da definire 25/03/2022 Read detail

Medical Devices Technical Expert - Orthopaedic

JOB DESCRIPTION

ECM – Ente Certificazione Macchine is seeking for an engineer with experience in the orthopaedic sector, to be included in its Medical Devices Division.

The candidate will be responsible for:

  • assessment of the documentation related to the product categories for which he/she will be qualified;
  • assessment of QMS requirements according to the standard ISO 13485.

 

REQUIRED QUALIFICATIONS

  • University degree or post-graduate degree in medical field, such as biomedical engineering, biotechnology or equivalent;
  • 3/5 years’ experience in the medical device sector, with particular reference to orthopaedic medical devices;
  • Excellent knowledge of the English language (minimum B1 level skills);
  • Knowledge of the regulations and technical standards applicable to orthopaedic medical devices;
  • Availability for occasional national and international travel.

 

WORKPLACE

The work activity could be carried out remotely based within the European Union, or at the ECM office in Valsamoggia (BO), Italy.

 

The job offers is addressed to candidates of both sexes

Medical Devices Technical Expert - Orthopaedic

TOP