Sr. Principal Engineer (Light & Surgical Instrumentation) M/F/X

TISSIUM; Paris; Sur place; EUR 110 000 - 140 000; Plein temps

Résumé du poste

The Light & Surgical Instrumentation Sr. Principal Engineer at Tissium serves as the technical authority for R&D activities related to electromechanical devices, driving high-impact decisions across programs.

The role requires leading cross-functional teams, shaping device strategy, mentoring engineers, and ensuring compliance with design controls and medical device regulations, including IEC 60601/62304, ISO 13485, and ISO 14971.

Qualifications

• Engineering degree or equivalent.
• 12-14+ years of experience developing electromechanical medical devices.
• Proven track record leading project teams and technical documentation.
• Deep understanding of design controls and medical device regulations (ISO 13485, ISO 14971, IEC 60601, IEC 62304).
• Experience with software in medical devices is preferred.
• Excellent communication in English (written and verbal).

Responsabilités

• Act as technical authority for electromechanical devices, including light devices and surgical instrumentation.
• Define deliverables for light devices and ensure thorough documentation for informed decisions.
• Lead work packages across complex projects, overseeing design, testing strategy and DHF documents (IEC 62304, IEC 60601).
• Identify opportunities and drive resolution of complex technical challenges shaping technology direction.
• Develop and monitor strategic plans and budgets to meet short- and long-term goals.
• Mentor engineers and foster cross-functional collaboration; manage risk.
• Coordinate with external vendors for testing, analysis, and production activities.
• Apply Quality Management System procedures and medical device regulations.

Connaissances

Tech leadership

Electromechanical design

Project management

Regulatory knowledge

Mentoring

Cross-functional collaboration

Formation

Engineering degree or equivalent

Description du poste

Tissium 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 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 (Deputy CEO & Chief Innovation Officer).

We are developing polymers for atraumatic tissue repair in various applications. Today, these polymers are used for sutureless 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.

YOUR MISSION

The Light & Surgical Instrumentation Sr. Principal Engineer acts as the technical authority for R&D activities related to electromechanical devices (with and without software), driving high-impact technical decisions across projects and programs. This role applies technical expertise across multiple projects and programs, provides technical and functional oversight, identifies new opportunities, anticipates and solves complex challenges with high impact on technology, product and pipeline strategy, mentors engineers, and develops and monitors strategic plans that meet the organization's short- and long-term goals.

RESPONSIBILITIES

• Technical authority for activities related to electromechanical devices, including light devices and other surgical instrumentation.

• Defines the deliverables related to light devices and other surgical instrumentation, ensuring the thoroughness, quality and timely delivery of documentation and data to inform project decisions.

• Leads selected work packages across different and complex projects, acting as technical authority for concept/device design, testing strategy and the development of technical documentation, including device inputs/outputs, risk management, designs/drawings/specifications, study plans/reports, and other DHF documents, including but not limited to IEC 62304 and IEC 60601 related activities.

• Identifies new opportunities, anticipates and leads the resolution of complex technical challenges, delivering solutions that shape technology direction and strengthen product strategy and pipeline.

• Develops and monitors strategic and project plans — including work packages and budgets — to achieve the organization's short- and long-term goals, acting as or in collaboration with the Project Lead.

• Proactively assesses project and device risks and applies sound risk management practices to identify, manage and mitigate risks.

• Drives collaboration within cross-functional project teams and with external experts, facilitating clear and structured communication to ensure a seamless flow of information, drive device progress and resolve challenges.

• Mentors engineers and contributes to their performance and skills growth.

• Supports the selection of and coordinates with external vendors and suppliers for testing, analysis, documentation, part supply and production activities, ensuring adherence to timelines, budgets, specifications and quality requirements.

• Identifies and implements improvements to practices, procedures and products, sharing best practices and contributing to continuous improvement activities.

• Applies company procedures, Quality Management System documentation and applicable Medical Device regulations.

YOUR BACKGROUND

• Engineering degree or equivalent.

• 12-14+ years of experience in the design and successful development of electromechanical medical devices, depending on achievements in the relevant field.

• Proven track record of leading project teams.

• Experience authoring technical documentation, testing, data analysis and interactions with regulatory authorities.

• Deep understanding and application of design controls, risk management, and medical device regulations, such as ISO 13485, ISO 14971, IEC 60601 and IEC 62304.

• Experience with software in medical devices is preferred.

• Excellent communication skills in English (both written and verbal).

TISSIUM BEHAVIORS & MINDSET

• Act with a sense of urgency: Drive a culture of execution, accountability, and timely delivery aligned with critical milestones.

• Embrace calculated risk-taking: Make informed and thoughtful decisions that create positive cross-functional impact.

• Continuously learn and share: Foster a strong learning mindset, encourage knowledge sharing, and support team development.

• Challenge the status quo: Constructively question existing practices to improve systems, processes, and outcomes.

• Balance tactical and strategic thinking: Combine operational excellence with a clear mid-term vision and strategic priorities.

• Assume positive intent: Build trust and foster constructive, respectful, and psychologically safe collaboration across teams.

• Drive active collaboration: Coordinate multiple stakeholders effectively around shared objectives and business priorities.

• Own outcomes: Promote accountability and take responsibility for measurable project results and deliverables.

• Strive for excellence: Drive sustainable improvements in quality, compliance, operational performance, and continuous improvement.

WHY JOIN US

• A dynamic and stimulating environment, with a culture focused on initiative, learning, and continuous improvement.

• Real opportunities for growth and development, with evolving career paths and tailored training.

• The chance to join an ambitious startup at the forefront of high-impact medical innovation.

• A strong commitment to ESG, embedded in strategy from day one.

• Attractive conditions: work-life balance, competitive package, and internal mobility (Paris, Roncq, Boston).

• An international and diverse environment, with more than 19 nationalities represented.

HIRING PROCESS

• Talent Acquisition Manager interview - 30 mins

• Manager interview (VP, Product Development) - 1 hour

• Technical Interview - 1 hour

• Team & Culture Fit Interview - 90 mins, on-site or videoconference