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“Great things in business are never done by one person.
They’re done by a team of people.” - Steve Jobs
We are looking for an “Embedded Software Engineer” with amazing skills in embedded systems. The candidate will be part of the R&D team, working on the design, development and maintenance of the embedded software executed on our Laser devices.
As main task/activities, he/she will manage autonomously every aspect of the software lifecycle process, from the SW requirements and architecture up to the verification and deployment; He/she will collaborate with R&D Team in SW system design, SW system Architecture review, FW/SW and HW/SW integration.
Moreover, as minor task, the candidate will be in charge of System Configuration of PC Embedded and Manufacturing support (i.e., Bios or OS installation, Device configuration).
- a degree in Software Engineering or Computer Science
- Good knowledge and programming skills in C++ (QT Libraries) and C# (.Net framework) language for embedded systems;
- Good knowledge of Software Development Environment (i.e., QT Creator, MS Visual Studio, ….);
- Good knowledge of Embedded Software Operative System: Windows10 IoT and Linux
- Creative problem solving skills;
- Knowledge of configuration management tools (Subversion)
- Write technical documentation (Design, Implementation and Verification documentation)
- Strong analytical and troubleshooting skills, self-motivated and autonomous;
- Flexibility and openness to changes, with good communication skills;
- Fluent written and oral English skill
- Available to short (and actually infrequent) business trips, both in Italy and abroad
- Good GUI (graphical user interface) design attitudes
Preferred skills :
- at least 1-3 years of experience in Software Design and Development, even better in relevant or safety-critical application fields (Medical, Automotive, Aerospace);
- Structured coding, Static Analysis, code review;
- Knowledge of main embedded communication protocol: TCP/IP, USB, RS232;
- Knowledge of IEC62304, ISO 14971, ISO 13485, AAMI TIR32:2004; FDA guidelines (21 CFR part 820); IEC/TR 80002-1;
- Teamwork attitude for effective and efficient collaboration within the R&D department and with other departments (Regulatory, Operations, Marketing, Service);
- Basic knowledge of Product Risk Analysis, and relevant documentation
- Knowledge of Python language and Python environment;
Varese province, Lombardy, Italy
Entry-Level or Mid-level
In order to empower our technical writing dept., we are looking for a Document assistant, who , reporting to the document coordinator, will have the following main responsabilities:
- Editing, updating and managing the technical documents pertaining to the products, their production and their technical assistance, with particular care to the CE technical files;
- Supporting the coordinator in the impact assessment of the changes
- Be responsible of the maintenace of manuals and related translations
- Contact with suppliers and consultants for translations
- Supporting in the writing of internal test reports
- Be involved in the risk analysis
- Supporting in the communication with other departments
The ideal candidate:
- Has a technical master degree, preferably in bio engineering or physics engineering:
- Has fluent written and spoken English, good knowledge of other languages, is a plus
- Is proficient in Microsoft Office
- Has a good knowledge of illustration and InDesign is a plus
- Has a strong passion for technical writing and understands the importance of good looking docs for end users
- Highly committed, great team player, capable to build positive relationships with colleagues
The successfull candidate shall live in Milan /Varese Area.
We are recruiting a QA Specialist –maternity cover
– works together with the Quality Control Manager to identify areas for improvement and to implement internal projects aiming at constant betterment, ensuring the compliance with the mandatory requirements and quality standards.
– operates complying with the regulation ISO 9001:2015, ISO 13485:2016, as well as US regulation, specifically 21 CFR 820; furthermore, granting the compliance with internal practice and quality plans agreed with the clients
– is responsible for keeping the Quality System documentation as well as necessary recording, controlled distribution and filing.
– cooperates in managing and evaluating customers’ complaints and manages the potential corrective actions arising.
– is responsible for recording non compliance cases and CAPA and also collaborates in RCA as well as in the implementation and performance review.
– Supports the execution of the Audit’s plan, both internally and externally (suppliers) and manages their related follow ups.
– supports the Quality System Manager in the audit monitoring ISO 9001/ISO 13485, factory inspections for branded products, clients’ audit, FDA inspections…
– is involved in statistical analysis, internal KPI monitoring and reporting
– collaborates in managing and assessing clients’ complaints and the related management of potential corrective actions arising, including issuing and managing reports to CAs
The ideal candidate:
– has at least 1-2 years of experience in the same position within medical companies (preferably electro medical ones) that are certified ISO 13485 as well as experience in FDA (application of 21 CFR 820 requirements)
– has previous experience or training in MDSAP (and related relevant regulation on quality system) and new MDR (New Regulation Medical Device 2017/745) will be considered as additional assets.
– is fluent in English, written and oral
– is proficient in MS Office
– has a degree in technical / management studies (information / managerial / biomedical engineering)
– has good interpersonal skills, is capable of working independently and in team with good organizational skills
– type of contract offered temporary contract for maternity cover
The Quality Control Officer will report to the Quality Control Manager regarding verification of raw materials, “in process” materials and will support the verifications on finished products.
– carries out dimensional / aesthetic / functional / documental examinations of components for semi-finished and finished products in the various production stages to assess and classify eventual faults;
– records the outcomes of the assessments carried out in accordance to the company’s procedures
– manages the filing of the documentation that has been created and verified during the testing phase
– participates in and provides input to managing eventual non-compliance arising from the verifications
– is actively involved in the evaluations of non compliance from process (components, semi-finished, finished products).
He is responsible for issuing the documentation about quality control and non-compliance registrations and their archive
– capability in using mechanical measurement instruments (gauge, micrometre, comparator…)
– design capability with mechanical design and with tolerancing as defined by reference standards
– basic knowledge of the main mechanical processing and superficial treatments
– capability in identifying aesthetics and functional defects of the goods to be tested
– capability in issuing documentation and reports about validation and verifications
– detail orientation and ability to perform the assigned tasks with minimal direction
– high school degree in technical studies, preferably mechanic.
– knowledge of English
– general understanding of electrical systems and the main electromechanical components
– good understanding of ISO 9001 and ISO 13485 regulations as well as FDA CFR title 21 part 820 requirements
Spirit of observation and intellectual curiosity, accuracy and attentiveness are also required.
The ideal candidate is capable of working in a team under the supervision of managers and collaborators, has the ability to achieve results with minimal direction and to liaise with the other company’s departments involved in the process.
The successful candidate will be directly hired by the company.
We are recruiting the Head of Product Engineering. Directly reporting to Operations Manager, the selected candidate will have to perform the following tasks:
- industrial production of new products and project revision for selected products already existing, with particular reference to: project revision of parts / products, detailed analysis of the costs for single parts and processes, analysis of the standardization of components / products
- feasibility analysis
- Times Study and Methods Engineering, Project Progress Report
This role requires an effective communication with all teams, both internal and external, specifically R&D, IT, Purchasing Department, Production and external suppliers of mechanical components.
The target set for this position is to deliver new products from a development phase to a production phase, as well as to review the design of some existing products as quickly as possible (product launch), ensuring the maximum economic efficiency thanks to the combined industrialization processes of engineering, supply chain and production.
This position is currently not present within the company.
The ideal candidate has a high school degree / bachelor degree in mechanical studies as well as 3/5 years of experience in the same position, preferably in the mechanical sector.
- Familiar with mechanical design software
- Must be able to read, write, speak and understand English.
- Capability in evaluating the purchase price of the mechanical and carpentry components
- Strong goal-oriented attitude
- Outstanding problem solving skills
- Excellent interpersonal skills and team working skills
We are recruiting a professional with technical / medical background to write user manuals and product documentation.
The ideal candidate:
- has a bachelor degree in technical, biomedical or engineering studies
- has expertise (even minimal) in creating technical documents to support the production and the certification of new products as well as writing manuals.
- is fluent in English and preferably in a second language
- is fully proficient with Office Suite and familiar with InDesign
The candidate will have to interact with various department within the company (R&D / regulatory / marketing / production) to organically collect all the necessary info in order to gain the full knowledge of the product and its related regulation.
The ideal candidate is accurate, methodical and capable of proactively and cooperatively interact in the various phases of designing a new medical device.
The successful candidate will be directly hired by the company.