Stilla Technologies

Stilla Technologies

Senior Engineer & Project Lead in Consumable Development (H/F) - CDI

  • CDI 
  • Villejuif
  • > 3 ans

Le poste

Senior Engineer & Project Lead in Consumable Development (H/F) - CDI

  • CDI 
  • Villejuif
  • > 3 ans

About

Stilla Technologies is a Life sciences company whose mission is to improve health by offering researchers and clinicians worldwide solutions for high precision genetic analysis.

Since 2016, Stilla Technologies has empowered researchers with the naica® system, a solution that enables to detect & quantify nucleic acid with unprecedented precision.

The naica® system supports a wide range of genetic tests and molecular biology assays — including liquid biopsy tests for cancer diagnostics, viral load quantification, GMO detection, etc… Overall, the naica® system superior performances make it a preferred technology for precision medicine research and therapeutic monitoring.

Stilla® advises and supports its customers worldwide with a multidisciplinary team, whose expertise spans from microfluidics and chemistry to molecular biology and computer science. Stilla’s talented and multidisciplinary team shares a passion for building successful Life Science and Diagnostic products based on deep technological innovations.

Job description

The Consumable Development Engineer will integrate the Consumable Development group, wthin the Product Development department. He/She is responsible for developing the consumable in accordance with user requirements, while respecting quality, regulatory, timeline, and budget constraints of the project. Technical lead of the development of a new consumable, he/she ensures and oversees the
conception, development and optimization of new consumables designs and prototypes, and
associated tools and processes for production, while improving the design and production
processes of existing products.

Main missions

Leading new consumables development projects
Structure new consumables projects in accordance with the Design Control quality process:
o Define product specifications based on Innovation feasibility proofs, marketing requirements, quality & regulatory requirements, industrialization, scale-up and production requirements, while considering the constraints of cost, resources, and time of the project.
o Identify the resource requirements and the development parts to be outsourced or
internalized.
o Propose and implement smart engineering and technical solutions.
o Plan in detail the developments, track progresses and ensures quality, delays and development costs constraints are respected
o Create, oversee, and validate quality associated documentation.

Lead new consumables developments:
o Lead, coordinate and take part to the conception, development, and optimization of prototype consumables according to specifications.
o Lead, coordinate and take part to the conception, development, and optimization of prototype tools and processes for production and characterize performances on prototype consumables or pilot batches according to specifications.
o Lead and coordinate developments of new designs, prototypes, tools, and processes with suppliers, sub-contractors, and service providers, specifying, reviewing, and qualifying their work according to specifications.
o Ensure internal training and communications necessary to ensure timely transfer of key product knowledge to the Commercial Operations team and other internal teams (Industrialization, Quality Control).
o Cooperate with the Marketing and Commercial Operations teams for successful New Product Introduction

Leading existing consumables improvement projects
Lead, coordinate and take part to existing consumables improvements projects in accordance
with the Design Change quality process.

o Support Operations team in solving non-conformities and implementing corrective and preventive actions
o Define new specifications for existing products, based on needs for improvement identified from marketing requirements, quality & regulatory requirements, industrialization, scale-up and production requirements, etc.
o Lead, coordinate and take part to the improvements and optimization of existing consumables, tools, or processes according to specifications.Working efficiently in a matrix organization
o Lead and coordinate projects activities with other team members, including Innovation, Assay Development, Bioinformatics & Software, Product Development, Manufacturing Operations, Marketing, Commercial Operations and Quality Assurance resources.
o Share results through oral/written presentations, technical reports, production files, etc.
o Ensure an efficient communication and interaction between departments and smooth information transfer.

Preferred experience

Our ideal candidate:

  • Must have at least 3 years of proven project management, with a track record of growing responsibilities and achievements (ex. successful product launches).
  • Has a PhD or master 2 level / engineering degree, ideally in the medical device field, in Mechanics, Physics, Microfluidics or a related topic.
  • Has a strong experience managing complex R&D programs involving multiple contributors internal and external, combining multiple fields of expertise distributed internationally.
  • Is already familiar with quality & regulatory standards in the field, ex. ISO 13485, IVDD or IVDR, ISO 23640 (stability studies)
  • Shows team spirit, with excellent communication skills.
  • Is pro-active, autonomous, and rigorous.
  • Has a strong ability to prioritize, and is results oriented and customer centric.
  • Has the capacity to coordinate and oversee suppliers, sub-contractors, and service providers.
  • Likes to interact with multiple teams and interfaces.
  • Can manage and coordinate transversally.
  • Must speak French and English fluently

Recruitment process

Why join us?
• Build amazing tools for Focused Genomics in a challenging environment
• Join a young and dynamic Life Science company
• Work with a team who shares a passion for building successful Life Science Products based on deep technological innovations.

Meet the team

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