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Senior Project/Program Manager Medical Devices

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Senior Project/Program Manager Medical Devices

Senior Project/Program Manager Medical Devices

Location: Zurich, Switzerland

Responsibilities:


Lead and manage cross-functional projects, orchestrating a wide variety of disciplines such as market research, clinical research, data analytics, software, electronics and mechanics, and coordinating the functions of marketing, development, quality, regulatory affairs and operations of each project

Ensure that the project objectives, compliance, internal and external requirements and timelines, budgets and high quality standards are met

Own, coordinate and communicate decision making in the project

Provide expertise, guidance and coaching to project staff on all aspects of project and product deliverables.

Identify and assess project risks and take appropriate measures

Collaborate with the Director Regulatory Affairs & Quality Management to ensure compliance and control for new product implementations and product updates

Manage and maintain the Design History File (DHF) throughout the project

Lead project change control activities internally and ensure appropriate documentation of these

Communicate with all stakeholders, from the board/management level to the team members and keeping them informed about the current project status at all times and to keep an overview of all related project subcomponents

Actively manage the critical path of projects by identifying bottlenecks, conflicts and resource shortages and defining appropriate actions together with the line managers

About you:


Master's degree in engineering, life science, business administration or other relevant area

Minimum 5 years of experience in a project management role in the medical device industry

Proven experience in leading projects in the medical device space from end-to-end, i.e. from the project development phase until the market launch of the medical device

Solid experience in regulatory science, compliance and communication in the medical device/healthcare industry and knowledge of relevant norms and guidelines (ISO 13485)

Proven application of project management principles, preferably with a formal project management education

(such as PMP/PMI/CAPM, Lean Six Sigma or others)

Demonstrated ability to manage multiple, conflicting priorities, and work in a fast-paced, ever changing environment

Capability to make good decisions based upon incomplete information, navigate ambiguity, drive change and operate effectively in a fast-paced, entrepreneurial, results-oriented culture; start-up exerience a big plus

Excellent communication skills tailored towards all levels of stakeholders

Strong analytical skills and process-oriented work style with a structured, independent approach to work and focus on getting things done

Creative positive thinker with the ability to troubleshoot issues quickly and effectively

Willingness to work flexibly, in an interdisciplinary and international environment, depending on the current project status

Fluency in English and willingness to travel (up to 15%)

Passion for Ava, our values, our community, and our mission to advance women's reproductive health by bringing together artificial intelligence and clinical research

Would you like to contribute to a highly motivated team, with a lot of space for your own initiatives? If yes, please apply online or send your complete application to recruiting@avawomen.com.


We appreciate that you share our excitement for Ava. Please be aware that only fully documented applications (CV, motivation letter and supporting documents) can be considered.


Ava - Revolutionizing women's health


Naemi Benz, VP Operations


Should you not hear back from us within 4 weeks your application has unfortunately not been successful for the respective role.



Ava is a digital health company with offices in Zurich, San Francisco, Belgrade and Makati that aims to advance

women's reproductive health by bringing together artificial intelligence and clinical research. Our wearable device,

smart app and proprietary predictive algorithms empower women by giving them unique clinically researched

insights and personalized data about their menstrual cycle, fertile window, and pregnancy delivered in a way that's convenient and non-invasive. Ava was voted Best of Baby Tech at CES 2017, named a Women's Health "Editors' Choice" product and has been honoured as the best Swiss startup in 2017 and 2018. Our current key markets

include USA, Germany, Switzerland and UK.

Would you like to join us on our challenging adventure? We are looking for a calm and confident project/program manager experienced in taking the lead on strategic company wide projects from end-to-end. The prime focus of this role is the setup and tracking of new medical product implementations for hardware and software combined products, along the medical device development process.


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