Contact us - Albelissa

Industrialization / Manufacturing Engineer - Class III Biomedical Device

Job Title
Industrialization / Manufacturing Engineer - Class III Biomedical Device
Job ID
27654929
Location
Northern Italy,  TO 10010
Other Location
Description
Our client is searching for a Industrialization / Manufacturing Engineer - Class III Biomedical Device to have a key role in the design and implementation of the manufacturing process of a class 3 medical implantable device for the heart. 

 

Responsibilities

Transition from the R&D processes to GMP-compliant production (class 3, medical implantable devices).
You will be responsible for internal manufacturing processes/manufacturing technology, as well as key sub-contracted manufacturing processes in collaboration with suppliers.
The function includes responsibility for the technical manufacturing infrastructure, tooling-technology definition, qualification of equipment, process validation and process capability, technical documentation, process-monitoring, production-scalability strategies and user training, management/maintenance of internal equipment.

  • Provide and contribute to manufacturing requirements within the scope of and from product design to ensure technological partners and solutions meet project requirements.
  • Improve the manufacturing processes; new equipments design, processes, and manufacturing procedures
  • Create installation, maintenance, and servicing procedures and methods
  • Establish production process specifications, including the appropriate equipment specifications, production methods, production procedures, and production environment specifications
  • Implement and execute procedures, methods and plans for: process (re-)validation, process monitoring, process stability and -capability.
  • Coordinate and realize equipment and related infrastructure purchasing, installation and qualification per applicable GMP requirements
  • Implement procedures and methods to provide for adequate equipment availability and -reliability (continuity and capacity)
  • Key actor in building and maintaining the DMR (Device Master Record-ref. FDA 21CFR820.40), in alignment with the process responsible actors for the DHF (Sr. Mgr. R&D) and the DHR (Mgr. Production & Quality)
  • Key actor in building and maintaining the VMP (Validation Master Plan), in alignment with the process validation responsible actor for the equipment qualification and process validation (Production, R&D and Quality departments)
  • Risk analysis and risk management of manufacturing processes (internal and external in cooperation with suppliers),
  • Participate in the referencing, qualification and periodic evaluation of suppliers and sub-contractor

Qualifications

  • Proven track-record of at least 5 years’ experience, in a similar role in the medical device industry or in a comparable highly regulated industry.
  • University degree in Engineering (Mechanical, Industrial design, Physics, Automation, or similar)
  • English fluency, with openness to lean Italian
Required Skills

5+ yrs experience in a similar role in the medical device industry
University degree in Engineering (Mechanical, Industrial design, Physics, Automation, or similar)
English fluency
Optional Skills

Italian language skills
Openings
1

Option 1: Create a New Profile

CONTACTS

Albelissa S.r.l.
Headquarters: Via Rivoli 14, 10090 Rosta (TO) - Italy
Albesun India Private Limited
Plot #13, Phase-II, Kavuri Hills,
Madhapur
Hyderabad, 500081
India
Albelissa S.r.l. RO
Strada Rariştei 7, Sector 2,
022626 Bucharest
Romania
info@albelissa.com

IT: +39 011 1966 3400

DE: +49 914 2807 3599

FR: +33 970 440 789

US: +1 415 529 7659

Candidates may submit their resume for the positions listed, or create a profile should jobs arise that may match your skills and for direct contact from our organization. Please upload your resume in Word (recommended) or PDF format. Albelissa respects your data privacy and ensures that your rights under EU GDPR are protected. For more information please read our privacy policy, www.albelissa.com/privacy.php . Any questions or concerns regarding your personal data, please contact us at privacy@albelissa.com