Senior Product Development Manager (Medical Device) M/F/X

DESCRIPTION OF THE COMPANYTissium is a mission-driven 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.

Tissium's technology is based on research and intellectual property from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Women's Hospital), who co-founded 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 The Senior Product Development Manager will play a key role in leading and contributing to the development of new medical device solutions aimed at addressing unmet clinical needs. This position is part of the product development team and involves a combination of strategic planning and technical responsibilities. This includes collaborating with and integrating the technical aspects of the subteams operating within our Nerve vertical. The objective of this position is to provide a comprehensive strategic overview and to bring depth, innovation, and meticulous planning to the technical aspects involved in product development.
General Duties & Responsibilities

a) Own, compile, and manage associated Design History Files (DHFs) and ensure compliance to ISO 13485 and ISO 14971.

b) Conduct product development activities (design verification and design validation) in accordance with design control and product risk management procedures.

c) Work closely with the Program Manager to provide technical oversight for each project, prepare, execute and monitor Project Plans to meet agreed upon company goals and milestones, and ensure technical requirements are achieved.

d) Coordinate the technical tasks of the project with the key stakeholders following the project plans.

e) Produce, execute, supervise and/or manage key Development studies.

f) Lead the development team, ensuring regular and timely meeting conduction as well as team spirit across all functions.
Role-specific Duties & Responsibilities

a) Prepare, execute and monitor development project plans to meet agreed upon company goals and milestones.
b) Lead the project team, ensuring regular and timely meeting conduction and team spirit across all functions.
c) Produce, execute, supervise, and/or manage various product development activities.
d) With the different company stakeholders:

Coordinate the device improvement and range expansion.Coordinate manufacturing processes and testing strategies to meet product safety and performance in conformance with the company's quality and regulatory requirements.Support regulatory submissions, by creating and/or reviewing regulatory documents for submissions to Health Authorities and Notified Bodies.REPORTING LINE This job will report to the Senior Director, Product Development. YOU WILL LOVE THIS JOB IF You demonstrate effective and well-structured communication skills.You are capable of respectfully challenging ideas and offering alternative options for consideration.You possess a pragmatic mindset and take a hands-on approach to accomplish tasks.You excel in cross-functional collaboration.You have a player-coach mentality, meaning you can provide guidance and mentorship while also being able to actively participate and execute tasks.You have previous management experience, with the ability to motivate and engage team members and direct reports.You are adept at strategizing, executing, and delivering results even under pressure or in stressful situations.You love being in a startup and have prior startup experience.YOUR BACKGROUND • Bachelor's degree in Engineering.
• A minimum of ten years of experience in product development within the medical device industry.
• Proficiency in managing Class II and/or III device development and product ranges.
• Previous experience in FDA submissions, knowledge of relevant regulatory standards, and their application.
• Familiarity with the clinical applications of implantable medical devices.
• Excellent communication and technical writing skills in English.
• Experience in project management and conducting development studies.
• Ability to create well-structured and easily understandable technical documents and presentations.
• Proficiency in project management, including the use of Microsoft Project or similar project planning tools.
WHY JOIN US Evolve in a pleasant and stimulating environment, with a work culture that values acting with urgency, a willingness to take risks, a desire to learn, an ability to challenge norms, and a capacity to operate within a dynamic range.Scalable career paths: at Tissium, we invest in the training and professional development of our employees, with programs adapted to their needs. We believe in the importance of offering varied learning methods to allow everyone to flourish in their professional project.An opportunity to join an ambitious and innovative startup striving to address one of the most persistent medical challenges since the inception of surgical procedures.Join a MedTech company that is environmentally and socially committed, Environmental, Social and Governance (ESG) themes are anchored in our business model and as our business grows, we found it to be even more essential for us to strengthen and solidify our ESG strategy and commitments.Enjoy many benefits: Work-life balance | Possibility of teleworking | Attractive overall remuneration | Opportunities for internal or geographic mobility (2 sites: Paris, Boston and Industrial site: Roncq).An international work environment with team members from over 19 different nationalities, reflecting Tissium's commitment to diversity and its inherent strengths.HIRING PROCESS The journey starts with an interview with Talent Acquisition Manager (30 mins).Then a face-to-face (virtual) meeting with the Manager of the department you are applying to join (1 hour).This will then be followed by a Technical Interview to validate your practical job-related skills (1 hour).For the very final round, you will be invited onsite for a team and culture fit interview (1 hour 30 minutes).Intrigued? We'd love to hear from you! Apply today — we're 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 individual's voice is heard, making our processes lightweight yet efficient.

#J-18808-Ljbffr