We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. Recruitment activities are focused on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest demands on quality, ethics and discretion.   For our client, the company F. Hoffmann La Roche in Kaiseraugst, we are looking for a   Project Manager (m/f/d)   Description: As the Project Manager, closely collaborate with the Device Development Team Leader to drive theadvancement of drug delivery technology platforms and portfolio development, playing a pivotal role inthe successful delivery of life-changing medical devices to the clinic and market. Leverage a robustfoundation in both technical engineering and project management to strategically plan, execute, andoversee development projects, ensuring timely completion, cost efficiency, and full compliance withregulatory requirements.   The perfect candidate:The ideal Medical Device Project Manager seamlessly integrates technical, regulatory, and businessperspectives to drive projects from concept to industrialization, ensuring compliance, innovation, andpatient impact. Also we are looking for a combination of industry-specific expertise, robust projectmanagement skills, and a proven track record of delivering innovative solutions to drive the success ofour medical device projects - 15 plus years of experience in the medical device industry. The perfectcandidate has additionally stong problem-solving skills, high attention to detail, ability to work underpressure and meet tight timelines, resilient and adaptable to change and proactive and self-motivated   Work Hours Standard 40 h/ Week, Remote/Home Office: onsite   Task and Responsibilities Define project charter and scope. In collaboration with Device Development Leader, clearly define deliverables of the project following, making sure project assumptions, constraints and scope are shared and understood within the organization and within the overall Technical Development Team. Device Project deliverables: clearly plan project deliverables and forecast requirements, estimating team resources and budget. Project integration: generate comprehensive list of required documentation to make sure project information is readily accessible and allows seamless integration in collaboration with PMO for the overall projects portfolio. Manage change management for project scope changes, integrating a change-management mentality within a fast-paced and complex organization to assure constant stakeholders alignment. Schedule Management: Develop and maintain the project schedule, track progress. Budget Management: Plan and manage the project budget, monitor expenditures in collaboration with other governing committees and the overall Technical Development Team. Stakeholder Communication: Establish and maintain a solid communication with internal and external stakeholders, provide updates and regular status reports, manage expectations in a faceted stakeholder environment. Risk Management: Identify, monitor, and mitigate project risks and issues, informing Resource Management: Allocate and manage resources in collaboration with the Device Development Leader, including personnel and materials. Quality Management: Ensure project deliverables meet quality system requirements.   You must have these qualifications BA/BS + a minimum of 15 years total work experience with at least 10 or more year’s relevant business and/or technical experience in the medical device, pharmaceutical or biopharmaceutical industry preferably from a multi-site global company. (*****) Experience in drug-device combination products is considered an asset. At least 10 years Project Management experience - Project Management Professional (PMP) certification or equivalent is preferred. (*****) Proven experience in project management, including project planning, execution, and closure. (*****) Strong leadership and team management skills. Excellent communication and interpersonal skills. Proficiency in project management software (e.g., MS Project, Smartsheet, Trello). (*****) Solid understanding of project management methodologies (e.g., Agile, Waterfall). Ability to manage multiple projects simultaneously and prioritize tasks effectively. Strong foundation in engineering, biotechnology, or life sciences relevant to medical device development Understanding of clinical, regulatory, and manufacturing requirements to ensure smooth device development and industrialization. Proven track record leading development projects and an in depth knowledge to apply project management methodologies and Design Control requirements. Project Management: Successfully contributed to multiple medical device projects, ensuring timely delivery and adherence to budget constraints. Regulatory: Deep understanding of design controls, risk management, and quality systems (ISO 13485, FDA 21 CFR Part 820), with extensive knowledge of FDA regulations, ISO standards, and CE marking requirements to ensure strict compliance across all projects. Risk Management: Adept at identifying project risks and implementing mitigation strategies to ensure project continuity and success. High Performing Teams: Proven ability to cultivate, develop, and sustain high-performing teams that excel in collaboration, innovation, and efficiency. Stakeholder Management: Proven ability to communicate effectively with team members and stakeholders, fostering a collaborative environment.   Are you interested? Then Mr. Andre Amstad looks forward to receiving your complete application documents (CV, certificates and training certificates). We look forward to hearing from you. Please send your application by e-mail to amstad@we-make-it.ch We look forward to hearing from you.