About Linxens
Linxens is a global leader in micro-connectors, module packaging, antennas & inlays, and secure ID solutions, with over 40 years of innovation. Headquartered in Paris, France, we operate R&D centers and production sites across Germany, France, Sweden, China, India, Singapore and Thailand.
Our solutions serve industries such as telecommunications, finance, transportation, hospitality, e-government, healthcare, and the Internet of Things (IoT).... Visa mer
About Linxens
Linxens is a global leader in micro-connectors, module packaging, antennas & inlays, and secure ID solutions, with over 40 years of innovation. Headquartered in Paris, France, we operate R&D centers and production sites across Germany, France, Sweden, China, India, Singapore and Thailand.
Our solutions serve industries such as telecommunications, finance, transportation, hospitality, e-government, healthcare, and the Internet of Things (IoT).
Our employees’ expertise and know-how allow us to continually reinvent ourselves and meet our customers’ evolving needs, helping them grow and innovate. Therefore, we invest in developing our employees’ skills and career growth.
Working for Linxens means investing in your future. Our growth is creating great opportunities!
Below is the job description for open position
Responsibilities
Leadership, Process & Change Management
Successfully transition the diverse technical team into a unified, cross-functional project organization, establishing clear roles, accountability, execution discipline, and streamlined workflows to support the development of medical device components.
Design, implement, and enforce Design Control and Risk Management processes (DHF, FMEA) in line with CDMO, ISO 13485, and regulatory requirements.
Ensure local technical execution & project standard practices align with the R&D strategy defined by the Head of R&D in France.
Stakeholder Collaboration (Internal & External)
Collaborate with technical Sales team and engage directly with customers during early technical phases to translate complex user requirements into measurable and quantified engineering specifications.
Partner with purchasing to manage technical interactions with key suppliers, ensuring components and materials meet design and quality requirements.
Regulatory & Quality Assurance (RAQA)
Act as the technical owner of the Design History File (DHF), ensuring all engineering, validation, and risk management activities comply with ISO 13485, 21 CFR 820.30, and CDMO requirements
Oversee the Validation Engineer and Prototype Lab to execute comprehensive process validation activities (IQ, OQ, PQ), in close collaboration with Production and the local RAQA team to achieve final approval
Project Execution & Industrialization
In collaboration with the project organization, ensure the engineering team effectively executes the technical project portfolio, ensuring complex projects are delivered on scope, on time, on quality, and within budget
Qualification:
10 years of experience in management position, in addition to 5 years in medical device development or related manufacturing processes or components embedded in medical device.
Master’s / Bachelor’s in Mechanical Engineering / Manufacturing Systems, OR similar discipline.
Background in the medical device industry with in-depth experience in ISO 13485 and 21 CFR 820
Experience managing full product development lifecycle for medium- to high-complexity products in a formal project environment.
Project management capabilities; PMP certification or equivalent preferred.
Strong ability to implement and scale processes to support business growth while maintaining regulatory compliance.
Proven leadership experience managing cross-functional technical teams.
Fluent in Swedish and English.
Join Linxens to work in a multicultural environment, collaborating with leading tech innovators and making a global impact on technology.
LINXENS is an equal-opportunity employer that strictly prohibits unlawful or unethical discrimination. Moreover, as part of our CSR Vitality program, we have committed to recruit, hire, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity, national origin, age, mental/physical disability, marital status, or any other characteristic protected by law.
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