International Career Opportunities

We are looking for a full time Development Engineer to join our R&D department.

The role is involved in research, design and evaluate products, components, modification of product and process to meet new product requirements, applying knowledge of engineering principle and ensure conformance with applicable specifications.

This position has to deal with all departments and international colleagues and with external consultants and doctors/ surgeons.

The person will report to the Product Development Director.

This is a great opportunity for a person that shows motivation, persistence, open mind and proactivity.

Responsibilities:

• Participate in the definition of the design criteria and performance requirements of new products, components and modification of products

• Investigate, evaluate, analyze and test competitor products to find out opportunity for new products or OpTech, enhancements of existing products or OpTech

• Design new concept/product from 3D modeling to final design drawings to be released in each phase of the product development process (such as Concept, Architecture, Prototype, Product Release) according to product development process and strategy

• Execute modeling and FEA simulation in order to understand/develop the structural aspect of the product.

• Assist and coordinates outsourced engineering services in product development, design and simulation activities

• Test or assist/coordinate testing activity of models/products to assess feasibility, verification and validation, developing and delivering appropriate test plan, testing protocols and reports

• Oversee first uses of the designed products, cadaver lab and surgery, to ensure they perform and function according to specifications

• Investigate product failures and solve the problems by designing, or coordinate the design, of the required corrective action

• Collaborate in the team activity during the Product Development Process, such as Risk Analisys assessment, Product Operative Technique development, Design for Manufacturing studies, Project Planning, Quality Engineering aspect for product qualification, Regulatory activities for products registrations

Education and Business skills:

• Master’s degree in engineering with specialization in Mechatronic preferred
• A previous experience of 2 years in a similar role is required
• Experience with Electromedical devices preferred
• Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.
• Knowledge of design techniques, tools, and principle involved in production of precision technical plans, drawings, and models.
• Knowledge of the ISO60601 preferred
• Excellent written and verbal communication skills in English are required
• Good Microsoft Office knowledge

Other requirements
• Critical thinking
• Problem solving
• Team working ability
• Committed and determined
• Mature and positive
• Willing to travel if needed, according to projects and activities

What will you find?

• Friendly, warm, and innovative atmosphere
• Healthy, inspiring, and international and inclusive work environment
• Training and development opportunities
• Smart working model (two days per week)
• Competitive reward packages
• Social and company events
• Wellbeing initiatives (welfare)
• Canteen
• Benefits (Pension Fund- Health Insurance)

What do we offer?

• This is a full-time job
• Permanent contract
• Salary package range: 32.000/35.000 euro*

*Please note that this is a range; the complete salary package will be defined based on the seniority / skills of the person

Do you want to join us? Are you ready to make the difference? We look forward to your application. Please send it to careers@orthofix.com

We offer an excellent opportunity to join our Quality Operations team, based in Bussolengo (Verona), as Supplier Quality Engineer Supervisor, reporting to the Quality Operations Manager.
This role is ideal for a proactive and detail-oriented professional who enjoys working closely with suppliers, driving quality improvements, and ensuring compliance with strict medical device standards. You will play a pivotal role in supplier qualification, audits, and new product development activities, ensuring robust processes and high-quality products from our supply base.
You will work in strong collaboration with Engineering, Manufacturing, Regulatory Affairs, and Suppliers worldwide, acting as a key link between Orthofix and its partners.
What will your contribution be?
• Lead supplier qualification and approval processes (PPAP, FAI).
• Monitor and manage supplier performance KPIs, including SCAR handling and POF/FPY.
• Plan and conduct supplier audits to ensure compliance with internal and regulatory standards.
• Oversee external process validations and manage supplier scraps and returns.
• Support new product development, including definition and execution of control plans, FAI, and measurement tools setup (MSA, R&R).
• Collaborate with cross-functional teams to ensure robust quality standards during product launches.
What are we looking for?
• Master’s degree in Mechanical or Biomedical Engineering (or related field).
• 2–3 years of experience in a similar environment (medical devices, automotive, aerospace, or other regulated industries preferred).
• Fluent English, both written and spoken.
• Strong knowledge of supplier quality processes: technical drawings, process audits, MSA, 8D, FMEA, validation.
• Proficiency in Microsoft Office.
• Availability to travel up to 10–15%.
What soft skills are we looking for?
• Strong problem-solving abilities.
• Excellent communication and collaboration skills with suppliers and internal stakeholders.

• A team player with the ability to interact with operational departments.
• Detail-oriented and organized, with a proactive and solution-driven mindset.
What will you find?
• Friendly, warm, and innovative atmosphere
• Healthy, inspiring, and international and inclusive work environment
• Training and development opportunities
• Competitive reward packages
• Social and company events
• Wellbeing initiatives (welfare)
• Canteen
• Benefits (Pension Fund- Health Insurance)
What do we offer?
• Full-time permanent position
• Salary package range: 40.000/45.000 euro*
*please note that this is a range; the complete salary package will be defined based on the seniority / skills of the person
Do you want to join us? Are you ready to make a difference?
We look forward to receiving your application. Please send it to: careers@orthofix.com

We offer an excellent opportunity to join our Process Engineering team, based in Bussolengo (Verona), as Process Engineer.

In this role you will take care of the planning and coordination of activities aimed at the industrialization of new products (production processes / technologies), in order to take care of business needs and the effectiveness of processes and costs.

You will work in strong collaboration with our R&D department, marketing, regulatory, planning, production, purchasing, quality engineering and suppliers.

What will your contribution be?

• Planning and coordination of activities aimed at the industrialization of new products (production processes / technologies): ES Chip removal – Assembly of components – Surface treatments)
• Definition of processes, equipment and production cycles with the aim of minimizing the “Time to Market”
• Identification and implementation of new technological solutions
• Optimization and updating of existing production processes
• Management, coordination and active participation in the construction, installation and implementation of new machines / equipment and in the modification and improvement of existing ones, in collaboration with the internal production, quality and maintenance functions and / or with any external suppliers
• Support in carrying out the process risk analysis, collaborating with the Product Engineering, Quality and Production functions
• Troubleshooting process or equipment problems
• Make or buy choices in collaboration with the Supply Chain and production departments
• Implementation of interventions for the continuous improvement of the production lines;
• Analysis of the value of both existing and developing products;
• Identification of activities useful for cost reduction;
• Development and improvement of production processes and technologies related to existing products and new ones;
• Management of documentation to support the production process (drawings, work cycles, operating procedures);
• Support and integration with the various company departments.
• Definition of production cycles, optimizing time, costs and quality

What are we looking for?

• Master’s Degree in Engineering or technical background /diploma
• Previous 3/5 years work experience in similar roles, preferably in innovation-oriented companies or operating in the mechanics or mechanical components sector
• Excellent written and verbal communication skills in English
• Proficiency in MS Office (especially Excel), CAD/CAM, Solid Works or Inventor.

What soft skills are we looking for?

• Curiosity, passion and proactivity
• Problem solving
• Good communication skills
• Team working
• Organizational and analytical skills
• Flexibility
• Innovation mindset

What will you find?

• A dynamic, international, and inclusive work environment.
• A friendly and collaborative team atmosphere.
• Training and development opportunities.
• Smart Working
• Competitive reward packages.
• Social and company events.
• Wellbeing initiatives (welfare).
• Benefits (Pension Fund – Health Insurance).

What do we offer?

• Full-time permanent position.
• Salary package: around 40k/45k (depending on seniority and skills).

Do you want to join us? Are you ready to make a difference?
We look forward to receiving your application. Please send it to: careers@orthofix.com

We offer an interesting opportunity to join our Regulatory Affairs team, based in Bussolengo (VR) as Senior International Regulatory Specialist, reporting to the Regulatory Affairs Manager.

This position ensures that global product international regulatory submissions activities are completed in a timely manner so that full compliance with all applicable global regulatory requirements and internal product/project goals is maintained. The person is also to assure availability of Technical Documentation File by preparing and maintain up to date the regulatory Product Application Files applicable for any new or modified Products. (e.g. EU-MDR Technical Documentation File, FDA 510(k))

Responsibilities include collaboration with Quality Engineering and R&D Departments and other functional areas in the application of all identified regulatory requirements for ensuring Technical Product Documentation File is adequate and accurate for successful regulatory submissions and approvals in each impacted country.

This position must deal with other company departments (mainly Sales) and international colleagues. Especially Consultants, Subsidiaries, Competent Authorities, Distributors, External laboratories, suppliers colleagues and Third-Party Regulatory agencies (NB, FDA, etc.).

What will your contribution be?

• Program, prepare and maintain up-to-date International product/facility(ies) submissions including international registrations and/or license applications, according to approved Budget Sales.
• Identifies, plans and collects regulatory submission documents for International markets under minimal supervision, in collaboration with Global Company(ies) departments.
• In collaboration with the team verify that all domestic and International Regulatory documents are adequately prepared and collected before the international Product(s) ‘ Application registrations.
• Provide in timely manner the RA Regulatory Intelligence Specialist (RIS) of any regulatory product registration/submission information status to able the RIS Specialist to update the RAMS platform on time.
• Contribute to prepare regulatory strategies for new/modified products in the planned markets.
• Provide market regulatory affairs support during external inspections (FDA, NBs, Regulatory Agency etc.).
• Plan and support the Regulatory Administration specialist for the preparation of Free Sales Certificate and any International documents to be legalized.
• Collaborates during Internal and Third Party Audits for Device Marketing Authorization and Facility
• Registration process.
• Manage any change(s) by ECO in Oracle system.
• Member of the NP team and Product Reviews Board, participating, preparing and assuring that the regulatory deliverables are duly prepared during the NP – Reviews processes in due time. T ransferring the identified Product input regulatory requirements to ensure proper and adequate technical documentation for product registration/licensing in respect to planned timeline.
• Edit and amend the Technical File structure and verifie regulatory conformity of Technical documentation in collaboration with Quality Engineering and R&D necessary for Products application submission in EU, US and ROW countries, as required.
• Prepares, reviews and maintain UpToDate Regulatory EU Product Technical Files and FDA Product Applications File in collaboration with departments, complete and accurate, available for regulatory Product(s) Applications submission on time for the planned submission deadline.
• Represents Technical Regulatory Affairs on assigned project(s) during the new/modified product Design Development phase and participate in cross-functional meetings with specific focus on product essential principles/requirements to provide regulatory perspective and interpretative knowledge.
• Manage any Deficiency and/or Nonconformity related to a RA Product Technical Files received by Authority or Third Party, in collaboration with other departments, by assuring a proper adequacy and regulatory conformity in the documentation impacted.
• Prepare and maintain updated Procedure Pack Files.
• Country codes management

What are we looking for?

• Technical degree
• 5+ years in similar position preferably in a Medical Device Company
• Excellent English written and spoken required
• Deep knowledge of international standards and regulations (in particular US-FDA/CFRs European MDR, etc).
• Project management. PLM system Oracle system
• Good management skills and relationship skills

What soft skills do you need?

• Precision
• Accountability
• Problem Solving
• Communication skills
• Multitasking projects and manage priorities accordingly

What will you find?

• Friendly, warm, and innovative atmosphere
• Healthy, inspiring, and international and inclusive work environment
• training and development opportunities
• Smart working model (two days per week)
• Competitive reward packages
• Social and company events
• Wellbeing initiatives (welfare)
• Canteen
• Benefits (Pension Fund- Health Insurance)

What we offer?

• Full-time permanent position.
• Salary package: around 43k/45k (depending on seniority and skills).

Do you want to join us? Are you ready to make the difference? We look forward to your application. Please send it to careers@orthofix.com

We offer an excellent opportunity to join our Clinical Affairs team, based in Bussolengo (Verona), as Medical Writer.

In this role you will work in a team environment to help develop global evidence-based clinical strategies for orthopedic medical devices by creating clinical documentation that systematically synthesizes information from multiple data sources.

You will plan and develop clinical evaluation reports (CERs), post-market clinical follow-up (PMCF) reports, as well as a summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs.

Your efforts support product approval, indication expansion and claim support, and mandated post-market requirements. You will interact mainly with departments involved in product development (e.g. Innovation, R&D, Regulatory & Quality, Sales & Marketing, PMO) in the company both at local and international level including relationships with US colleagues. You will also engage with external consultants, regulatory agencies and scientific organizations/companies.

What will your contribution be?

• Reviewing medical scientific literature, analyzing clinical risk and providing benefit/risk assessment, write, review and edit CERs to comply with international regulations.
• Write and update coherently and convincing CERs and PMCF Reports by organizing and evaluating large amounts of scientific/clinical/medical data.
• Prepare and update SSCP, according to the SOP, based on the CER and other sources, including the part for lay persons.
• Write and update CEPs and PMCF Plans.
• Work collaboratively with cross-functional partners.
• Prepare answers to the Notified Body or Regulatory Agency requests.
• Assist with other clinical, marketing and regulatory projects assigned.
• Acquire, interpret, analyze and draw conclusions from clinical data from clinical trials, literature and experiences for a wide variety of medical devices.
• Communicate scientific content in a clear, concise manner.
• Mentor and train new incoming team members about procedures and best practices.
• Preparing clinical collaterals in collaboration with Medical Affairs and Marketing
• Performing ad-hoc literature searches and analyses
• Where necessary, involve and managing outside consultants, vendors and experts (HCP and technical experts) for the execution of the above-mentioned activities

What are we looking for?

• PhD is required, preferably in medical or life sciences
• Previous 1/3 years work experience in similar roles, preferably in innovation-oriented companies or operating in the mechanics or mechanical components sector
• Knowledge of ISO 14971, AIMDD, MDD, MDR, MDCG, CMDCAS/ CMDR, JPAL and other international regulatory agency requirements.
• Experience with literature research, publications, and journal articles.
• Familiarity with citation management software.
• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Medical Devices.
• Knowledge with Design History File, Technical File, Design Dossier, Clinical Study Report, and Clinical Evaluation Report content templates.
• Working knowledge of current electronic document management systems and information technology.
• Good English knowledge written and spoken
• CERs, post-market clinical follow-up (PMCF) reports expirience

What soft skills are we looking for?

• Able to assimilate and interpret scientific content and translate information for appropriate audience.
• Able to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
• Able to manage time efficiently and prioritize tasks.
• High attention to detail and accuracy.
• Able to manage complex tasks.
• Strong interpersonal skills, ability to work with teams and be a self-initiator.

What will you find?

• A dynamic, international, and inclusive work environment.
• A friendly and collaborative team atmosphere.
• Training and development opportunities.
• Smart Working
• Competitive reward packages.
• Social and company events.
• Wellbeing initiatives (welfare).
• Canteen.
• Benefits (Pension Fund – Health Insurance).

What do we offer?

• Full-time permanent position.
• Salary package: around 40k/45k (depending on seniority and skills).

Do you want to join us? Are you ready to make the difference? We look forward to your application. Please send it to careers@orthofix.com