Manufacturing Process Engineer

Join our Team at Creanova, Create & Innovate Healthcare Solutions for a better quality of life!

Creanova is a B2B partner specialized in the development and contract manufacturing of innovative medical and electromedical devices.

We operate in an international, multidisciplinary, and regulated environment, supporting projects from the development phase through to industrialization and mass production.

For our Como, Italy site, we are looking for a Manufacturing Process Engineer to join our growing team.

The Role

The selected candidate will be responsible for the correct transfer of medical devices from design to production, in compliance with the Quality System requirements and the ISO 13485 standard. They will actively manage Design Transfer, definition of processes and related documentation, and project costing, maintaining a complete vision of technical, production, and economic aspects.

The role involves constant collaboration with R&D, Project Management, Quality, Purchasing, Supply Chain, production, clients, and suppliers, with direct responsibility for meeting production requirements, timelines, and defined costs.

Main Responsibilities

• Design Transfer and Industrialization: manage the transfer of devices from design to production, verifying feasibility, completeness of documentation, and readiness of processes, equipment, controls, and tests.
• Technical Product Analysis: analyze drawings, specifications, customer requirements, and BOMs, identifying production processes, constraints, risks, and missing information.
• Production Process Definition: define and formalize process flow, assembly cycles, layouts, equipment, intermediate controls, functional tests, and acceptance criteria.
• Project Costing Management: prepare and update production cost estimates, considering materials, components, labor, equipment, validations, external processing, logistics, and production risks.
• Cost Monitoring: analyze deviations from initial quotes, identifying causes and proposing corrective actions or optimization opportunities.
• BOM and Production Documentation: prepare, verify, and maintain BOMs/mBOMs, PFMEAs, Work Instructions, process flows, Quality Control Plans, and production documentation in compliance with the quality system.
• Start-up and Validation: plan and coordinate prototypes, pilot builds, Design Verification builds, IQ/OQ/PQ activities, and product introduction into serial production.
• Change Management: evaluate the impact of product or process changes on costs, documentation, equipment, controls, and validation activities.
• Production Support: manage technical issues, non-conformities, and assembly criticalities, coordinating root cause analysis and improvement actions.
• International Collaboration: coordinate with Italian and Serbian teams, clients, and suppliers, ensuring technical, production, economic, and documentary alignment.

Qualifications

• Degree in Biomedical, Mechanical, Management, Industrial Engineering, or a related field.
• Approximately 5 years of experience in industrialization, process engineering, manufacturing, product development, or related technical roles.
• Experience in managing Design Transfer activities and introducing new products into production.
• Good knowledge of production processes and ability to analyze technical drawings, specifications, BOMs, and product requirements.
• Experience in preparing production cost estimates and analyzing materials, times, labor, and investments.
• Knowledge of PFMEAs, Work Instructions, Quality Control Plans, and production documentation.
• Good command of Excel and familiarity with ERP systems or tools for managing BOMs and project data.
• Structured approach, autonomy, analytical skills, problem-solving abilities, and result orientation.
• Ability to coordinate cross-functional activities and interface with clients, suppliers, quality, production, and project management.
• Willingness to travel to suppliers and production sites, including the Serbia site.
• Good knowledge of the English language, at least B2 level.
• Good knowledge of the Italian language, at least B2 level.
• Category B driver's license.

Considered a plus

• Experience in the medical device, electromedical, or other regulated industrial sectors.
• Knowledge of ISO 13485, ISO 14971, PFMEA, Design Transfer, and process validation.
• Experience in preparing Contract Manufacturing quotes and in the technical-economic evaluation of suppliers.
• Familiarity with ERP systems, 2D/3D CAD tools, and BOM management software.
• Knowledge of technologies such as injection molding, CNC machining, electromechanical assembly, electronics, and functional testing.
• Experience in Lean Manufacturing, root cause analysis, and continuous improvement.

What We Offer

We offer the opportunity to join a dynamic, technical, and growing environment, active in the development and realization of high-value medical devices.

The selected candidate will have the opportunity for:

• A career path for growth and training in Manufacturing Process Engineering applied to medical devices.
• The opportunity to follow projects completely, from Design Transfer to mass production, understanding both their technical and economic aspects.
• A role with a concrete impact on production feasibility, costs, and project success.
• An international and multidisciplinary environment, in contact with clients, suppliers, and production teams.
• A collaborative, dynamic team focused on quality and skill development.

Are you interested in understanding how a device goes from design to production and want to grow in a role that combines technical skills, processes, and costs? Apply and tell us about your journey: we'll be happy to meet you!