Website Aspivix_Health Aspivix

Modern Solutions for Gynecology Designed for Clinicians and Women.

We offer:
• A dynamic working environment as part of a start-up.
• Working in a MedTech startup that 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 to developing products with bigger potential. Your imagination and willingness are the limits.
• A 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 of 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 the 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.
o Leadership Activities
§ Foster the cooperation between diverse disciplines and functions managing a good balance between discussion, consensus, argumentation, and decisiveness.
§ 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.
o 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 the decision process and decision-making.
• Experience & Education:
o Master/Ph.D. 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.
o Proven knowledge and experience in project management and technology development. Exposures to developments as well as verifications and validations of launched medical devices, including at least one product cleared by the FDA.
o 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.).
o Experience in Start-up is a strong and determinant plus.
o Experienced in leading cross-functional teams (Clinical, Regulatory, Operations, R&D, etc.) to successfully achieve goals.
o Fluency in English. German or French is a plus.

To apply for this job please visit www.aspivix.com.