Quality Engineer - Hernia Cardio MFX

DESCRIPTION OF THE COMPANY

Tissium is a missiondriven medical device company founded in 2013 headquartered in Paris with a production facility in Roncq (near Lille) and an office in Boston. We are dedicated to creating a new era of body repair by leveraging our biopolymer platform to develop new innovative solutions in surgery for a positive impact on patients lives.

Tissiums technology is based on research and intellectual property from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Womens Hospital) who cofounded the company with Christophe Bancel (CEO) and Maria Pereira (Chief Innovation Officer).

We are developing polymers for atraumatic tissue repair in various applications. Today these polymers are used for structureless nerve repair hernia repair and cardiovascular sealing

Since our inception we have raised a total of 170 million euros. Our latest fundraising round which concluded in April 2023 resulted in 50 million euros in additional funding. This infusion of capital provides us with the necessary resources to finance the commercialization of our first products.

RESPONSIBILITIES

We are seeking a motivated individual to join our growing team as aQuality Engineer (Hernia Cardio) to fulfil the followingmissions:

• Interfaces with R&D Manufacturing Engineering and Production to resolve quality related issues.
• Development and Execution of process and system improvements to improve Safety Quality Compliance Service Level to customers and product cost.
• Support team for change control process.
• Perform drawings/specifications review with internal crossfunctional team.
• Define incoming control (specification select right measurement tool training ).
• Assist on component qualifications (initial samples/first article approval).
• Risk Assessment committee quality referent Create update review and approve risk analysis (FMEA ).
• Perform and oversee equipment validations and process validations.
• Responsible for reviewing and approving test protocols and reports for Process Validation.
• Process deviation and nonconformity process owner.
• Internal and supplier nonconforming material report disposition.
• Detailed root cause investigation of failed product or processes.
• Lead or assist with developing/implementing effective corrective and preventive actions (CAPA).
• Advocate for the promotion of awareness of regulatory and internal requirements
• Support audits (preparation backroom ).
• Trainer for Risk Analysis and Nonconformity management.

The employee shall apply all regulatory requirements in place at Tissium by applying Tissium Quality Management System documentation.

REPORTING LINE

This job will report to the Quality Director.

YOU WILL LOVE THIS JOB IF

• You have a good understanding of manufacturing processes.
• You have great problemsolving skills.
• You are fluent in English and French as well as possess excellent written and oral communication.
• You are selfmotivated and selfdisciplined and able to prioritize and handle multiple tasks and responsibilities.
• You are able to work in a fastpaced technically challenging environment where drive is critical to success.
• You have good interpersonal skills including ability to interact with a high degree of diplomacy.

YOUR BACKGROUND

• Masters Degree in Engineering (Mechanical Biomedical Materials)
• Minimum of 5 years experience in Industry (Medical device pharmaceuticals biotechnology)
• Experience with inspection techniques understanding technical documentation including mechanical drawings.
• Knowledge of quality requirements for medical device manufacturing and requirements for inspection and testing.
• Experience with risk management and principles of ISO 14971.
• Experience in quality management systems for medical devices per ISO 13485.

WHY JOIN US

• A work culture that values urgency a willingness to take risks a desire to learn an ability to challenge norms and a capacity to operate within a dynamic range;
• A competitive salary;
• 50% reimbursement of transportation expenses;
• The flexibility to work in Paris Roncq or a hybrid arrangement;
• An international work environment with team members from over 13 different nationalities reflecting Tissiums commitment to diversity and its inherent strengths;
• An opportunity to join an ambitious startup striving to address one of the most persistent medical challenges since the inception of surgical procedures.

HIRING PROCESS

• The journey starts with an interview with Talent Acquisition Manager (30 mins)
• Then a facetoface (virtual) meeting with the Manager of the department you are applying to join (1 hour)
• This will then be followed by a case study or business case to validate your practical jobrelated skills (1 hour)
• For the very final round you will meet other teams in Tissium
• You will be asked to provide us with professional references including contact details.

Intrigued Wed love to hear from you! Apply today were standing by for your resume!

We firmly believe that building a company for everyone requires a diverse team. Our organization values diversity and welcomes applications from individuals of all backgrounds. We do not discriminate against employees or applicants based on gender identity or expression sexual orientation race religion age national origin citizenship disability pregnancy status veteran status or any other differences. Our company culture prioritizes human interaction and ensures that every individuals voice is heard making our processes lightweight yet efficient.