Senior Functional Analyst

at  Orthofix

We offer an interesting opportunity to join our R&D team, based in Bussolengo (VR) as Senior Functional Analyst reporting to the Software & Electronics Development Manager.
The Senior Functional Analyst plays a key role in the design, development, and deployment of software solutions that are part of the Orthofix Orthopedics’ product portfolio.
This individual will be responsible for gathering and analyzing business and clinical requirements, ensuring functional specifications align with regulatory standards, and supporting product development teams throughout the lifecycle.
He/she will collaborate with cross-functional teams to ensure that the software product meets user needs, regulatory requirements, and company objectives.
The person will communicate and interact with the relevant company functions (Marketing, Quality Engineering, R&D, Sales force …) and with surgeons and other professionals in medical industry.
What will your contribution be?

Requirements Gathering & Analysis:

• Lead the elicitation and documentation of business and functional requirements from key stakeholders (marketing, clinical, regulatory, engineering, etc.) for software products, medical device and non-., using Agile techniques like user stories, backlog grooming, and sprint planning.
• Develop clear and detailed functional specifications, user stories, and use cases that align with business objectives, Agile practices, and regulatory guidelines.
• Maintain and evolve product knowledge on the software’s history, development, and future direction.

Agile Team Collaboration:

• Act as a liaison between stakeholders and Agile development teams to ensure clear communication and alignment on priorities, functional requirements, and sprint deliverables.
• Participate in Agile ceremonies including daily stand-ups, sprint planning, backlog refinement, sprint reviews, and retrospectives to support team productivity and deliverables.
• Help define and prioritize the product backlog, ensuring features and functionality meet the needs of the business and regulatory standards.
• Collaborate with other Functional Analysts, Solution Designer and developers to define solutions that meet requirements.

Regulatory Compliance:

• Ensure that functional designs are aligned with risk management, usability, and regulatory requirements (FDA, ISO 13485, IEC 62304, etc.).
• Contribute to the preparation of documentation for regulatory submissions and audits, ensuring traceability from requirements to verification.

Testing & Validation Support:
Support the verification & validation process in collaboration with the Team by ensuring that user requirements are adequately verified and validated

Continuous Improvement:

• Stay up to date with industry trends, technological advancements, and regulatory changes to ensure the product remains compliant, competitive, and innovative.
• Foster a culture of continuous improvement within the team, encouraging feedback loops, retrospectives, and process optimizations.

Cross-functional Collaboration & Knowledge Sharing:

• Collaborate with cross-functional teams (product management, software development, testing, regulatory affairs) to ensure alignment and successful project execution Including flag potential risks, and help resolve challenges to meet quality standards and project goals
• Lead presentations and discussions around software products in development, both internally and with external stakeholders.
• Act as a subject matter expert for the development team and stakeholders, ensuring best practices and technical standards are followed.
• Train surgeons, sales teams, and other stakeholders on the effective use of the software solutions, providing expertise to support successful adoption.
• Collaborate with PMO and project management team to ensure alignment between technical deliverables and project timelines, supporting the planning and scheduling of key milestones.

What are we looking for?

• Bachelor degree – Software Requirements Engineering is a plus
• 5+ years experience relevant to the position
• Previous working experience in a regulated device industry or in a structured Company
• Fluent English knowledge

What soft skills will you improve?

• Proactive person, critical thinker, with excellent analysis and synthesis skills and very good communication and team working ability.
• Curious about continuous improvement and learning mindset.
• Ability to understand the bigger picture and ability to work and manage a certain degree of uncertainty.
• Pragmatic problem analysis and problem-solving attitude
• Attention to details and accuracy
• Team working attitude oriented driven by organization skills
• Excellent interpersonal skills, especially communication skill – verbal and written

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
• The contract is permanent
• Salary package range: 38.000/45.000 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 the difference? We look forward to your application. Please send it to careers@orthofix.co

Please refer the Job description for details