Website Aspivix_Health Aspivix
Developing Simple, Modern and Gentle Solutions to Meet Women's Healthcare Needs.
We offer:
- A dynamic working environment as part of a start-up.
- Working in a MedTech startup which will make a difference in women’s health and with a true mission; at ASPIVIX, we innovate women’s care because we believe that women deserve gentler and more modern methods for procedures in gynecology.
- A possibility to form your own job and to contribute developing products with bigger potential.
- Your imagination and willingness are the limits.
- An opportunity to develop a medical device from idea to launch.
- Co-operation with a nimble multinational team of brilliant and passionate colleagues.
- A chance to influence from the early beginning the course of a growing company.
About the role:
• Responsibilities:
o Core Responsibilities
- Lead an engineering team for new product development lifecycle per design
control procedures from concept inception through development, launch - Lead on R&D team, responsible for team management and development
- Manage professional and technical development of direct reports.
- Manage the activities and budget of the engineering team and the programs.
- Provide technical guidance and supports to cross-functional teams
- Lead projects from concept to commercialization, leading a cross-functional
team to execute projects with sound problem-solving methodology. - Plan and budget project and track program status and results; remove and
elevate project barriers for the team.
Leadership Activities
- Foster the cooperation between diverse disciplines and functions managing a
good balance between discussion, consensus, argumentation and - Lead others in the completion of project tasks and sub projects
- Smooth & facilitate the decision-making process.
- Create a work environment that supports team effectiveness.
- Provide feedback to team members.
- Assist with integration of common tools and techniques.
- Present to internal and external audiences, including board or investors.
- Expertise and Problem-Solving Duties:
- Identify resource requirements, cost, and time schedules. Develop an
implementation plan, conduct risk assessments and develop contingency
plans to accommodate unforeseen events. - As part of the management team, selects the specific action plans that will
best meet the identified business objectives. - Be part of the vision and translate vision to project goals, roadmap and plans.
- Analyze risks, suggest mitigation plans and develop alternatives to solutions.
- Proactively anticipate and identify risk areas; alert stakeholders appropriately.
About you:
• Soft skills:
o Is an Excellent team player in a multicultural environment.
o Shows a “Can-do-attitude” with agility.
o Has passion for medical device
o Is comfortable with decision process and decision making.
• Experience & Education:
o Master/PhD in science, engineering (Mechanical, Bioengineering, Electronics, or
related fields). PMP Certification or equivalent is a plus.
Minimum 5 years of R&D Management, ideally in MedTech for mechatronic products.
- Proven knowledge and experience in project management and technology
Exposures to developments as well as verifications and validations of
launched medical devices, including at least one product cleared by FDA. - A strong technical leader with good product design and process development skills
and experience, highly familiar with medical regulations and requirements (Design
Controls for Medical Devices Class I & II, ISO 13485, 21 CFR Part 820, Quality System
Regulation, etc.). - Experience in Start-up is a strong and determinant plus.
- Experienced in leading cross-functional teams (Clinical, Regulatory, Operations, R&D,
) to successfully achieve goals. - Fluency in English. German or French is a plus