Senior Medical Device Design Engineer Light and Electromechanical Devices 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.

We have raised a total of 170 million euros since inception. The last fundraising was closed in April 2023 for 50 million. This additional financing gives us a strong cashflow to finance the commercialization of our first products.

RESPONSIBILITIES

We are actively looking to recruit a Senior Medical Device Design Engineer to be an integral part of TISSIUMs Light & Electromechanical Devices team. This person will play a key role in the conversion of concepts into robust and safe products used to deliver and cure TISSIUM polymer implants in a variety of clinical scenarios. This person ensures that final solutions meet the performance usability and safety needs of our Users and their Patients.To achieve this will require leading the definition of clear and unambiguous project inputs identifying and managing key technical risks and working collaboratively across TISSIUM project teams as well as with external partners (e.g. manufacturing suppliers) to drive on time project delivery. Continued technical oversight post launch will also be required to support efficient and effective life cycle management of products once released.

Duties & Responsibilities :

Leads the integration of mechanical electronic and firmware/software solutions across the development and life cycle management of TISSIUMs product portfolio.
Supports the generation of and constructively challenges pre and formal Verification & Validation performance plans work packages and schedules across project teams ensuring the development of lean and efficient activities managing delivery of the Minimum Viable Solutions across projects.
Makes judgements over the overall effectiveness of the risk management process in relation to project patient user risks. Uses risk management tools to drive design/solution and ensures technical and project risks are highlighted and communicated at the appropriate level for awareness and is proactive in implementing appropriate action plans to mitigate those risks.
Perform analyses and technical evaluations to demonstrate that the product safety performance manufacturability and cost are consistent with the customer regulatory and production requirements.
Participate in supplier identification selection and collaboration to ensure efficient and effective processes are established to produce the parts and products required across TISSIUMs Light & Electromechanical Device platform.
Coordinate manage and integrate the needs of the industrialization team and or suppliers activities into the development and life cycle management of TISSIUMs product portfolio.
Participate in the preparation review and constructive challenge of Design History File and project documentation in compliance with Quality System Regulations (QSR) International Standards Organization (ISO) and company requirements throughout the project life cycle.

Job Environment/Interactions :

Effectively interfaces with Innovation Development Marketing SubContractor teams as well as Clinical Advisors to facilitate the success of TISSIUM product development & life cycle programs.
Challenges and supports concept and development activities to ensure safe reliable robust and manufacturable products are delivered in accordance with regulatory and customer requirements.
Provides constructive & robust challenge to subcontractors to ensure Quality & Value are delivered for TISSIUM whilst ensuring effective collaboration and engagement are maintained.

REPORTING LINE

This job will report to the Director of Light & Electromechanical Devices.


YOU WILL LOVE THIS JOB IF

You are Handson and have a Cando attitude.
oLeading by example driving project progress and accommodating of changes in tasks and priorities.
You are a team player.
oKnowing when to support and encourage others to deal with uncertainty difficulty or change.
Leads by example.
oSets SMART objectives and ensures they are understood and delivered by team members.
You can problem solve in a structured and logical manner.
oGenerating and presenting options for the mitigation of issues / risks.
You openly admit and accept your own and others mistakes.
oFostering a working environment of lessons learned inspiring confidence in team members to be open and honest about mistakes and suggest future improvements.
You can effectively collaborate with and manage others with a high level of integrity confidentiality and discretion creating a culture of success.
You are passionate about improving peoples and patients lives.

YOUR BACKGROUND

Engineering Masters degree or equivalent.
46 years experience in the development integration and release of mechanical electronic and firmware/software solutions within the Medical Device field.
Experience of risk project management and product development in a Medical Device or equivalent regulated industry.
Understanding of a wide range of engineering technologies used in design prototyping and manufacturing.
Excellent English communication and technical writing skills. being able to articulate complex and conceptual information to others in a meaningful and relevant way.
CAD preferably with certified SolidWorks experience.

WHY JOIN US

• An opportunity to join an ambitious startup addressing one of the most persistent medical challenges since the inception of surgical procedures.
• Fastmoving environment you will never stop learning and growing.
• International environment the team is composed of more than 13 different nationalities. Diversity is a strength at Tissium.
• Work onsite in Paris Roncq or Remoteflexible.
• Competitive salary package & benefits.
• Last but not least strong company culture with transparency as one of our values information is shared regular with the team!

HIRING PROCESS

• The journey starts with a phone interview with Talent Acquisition Manager (30 min)

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 technical review to validate your practical jobrelated skills ( 1 hour)
For the very final round you will meet other team members from Tissium for a team/culture fit interview.

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

We believe that in order to create a company for everyone we must also guarantee that it is built by a diverse team. We embrace diversity and invite applications from people from all walks of life. We dont 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. We are very processlight putting human interactions above and making sure that everybody is heard.