R&D Engineer Life Science

Joinrs; Lugo; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading technology company seeks an R&D Engineer to develop protocols and support design control in medical device projects. The ideal candidate will have at least two years of experience, a solid understanding of DHF, ISO 13485, and V&V activities. Responsibilities include creating test protocols, leading feasibility studies, and collaborating with various teams. This role offers an opportunity to contribute significantly to the product development process with a focus on compliance and quality in a diverse environment.

Competenze

• Minimum of two years in a similar R&D role.
• Hands-on experience with product verification and validation activities.
• Experience drafting and updating design documentation.

Mansioni

• Define and develop test protocols for medical device R&D.
• Lead feasibility studies in early project phases.
• Support design control and facilitate design transfer.
• Execute verification and validation activities.
• Analyze impact of design changes in collaboration with teams.
• Use laboratory instrumentation for testing.

Conoscenze

DHF knowledge

Design change management

ISO/IEC 13485 familiarity

V&V experience

Technical documentation review

Descrizione del lavoro

R&D Engineer – Life Science at Joinrs

This role involves developing protocols and supporting design control in R&D projects for medical devices. The position requires a solid foundation in DHF, ISO 13485, and verification & validation (V&V) activities, with a minimum of two years of relevant experience.

Responsibilities

• Define and develop test protocols to evaluate medical device performance during R&D.
• Lead technical and economic feasibility studies in the early project phases.
• Support design control activities and facilitate design transfer to production.
• Execute V&V activities in compliance with design and regulatory requirements.
• Analyze the impact of design changes and post‑production modifications in collaboration with Engineering, Quality, Production, and Risk Management teams.
• Use laboratory instrumentation for functional, performance, and benchmark comparison tests.
• Draft, review, and update design documentation (Design Input/Output, Test Plan, Test Protocol, Test Report).
• Maintain requirement traceability and support technical file / design dossier documentation.

Qualifications

• Knowledge of DHF.
• Experience managing design changes on products.
• Familiarity with ISO/IEC 13485.
• Hands‑on experience with product V&V.
• Experience reviewing technical documentation.
• Minimum of two years in a similar role.

Selection Process

Alten Italy will conduct the entire selection process. After CV receipt, the Talent Acquisition team will contact suitable candidates for introductory and technical interviews, possibly including practical tests. The interview sequence may vary based on needs.

EEO Statement

ALTEN operates in respect of principles of diversity, equity, and inclusion, ensuring a workplace free from barriers and prejudices, evaluating candidates independently of gender, ethnicity, disability (article 1 and 18, law 68/99), age, sexual orientation, religion, marital status, personal convictions, union affiliation, family responsibilities, and socio‑economic background. The organization is committed to providing an accessible and welcoming environment, honoring Law 68/99 for inclusion of protected categories.