R&D Lead - QA/Verification/Product file (w/m/f)

Permanent employee, Full-time · Garching bei München

Your tasks
As R&D Lead you will ensure that IVD devices comply with the highest standards for quality and safety, and produce reliable data to be used for diagnostic purposes.

Responsibilities: 
 
  • Lead the R&D verification, QA and testing team
  • Plan and perform testing (from time to time, if your team needs support) to meet all technical product specification
  • Ensure test coordination, planning and reporting consistent with Inveox directives and process execution guidance
  • Take Risk Analysis responsibility for products
  • One of our product workflow experts
  • Ensure ISO/FDA conform development documentation
  • Support Regulatory for FDA submissions
  • Support Regulatory during audits in R&D aspects
  • Assist Product and Customer service in case of complaints / complex questions about released products
  • Support of products under development at cooperation sites
  • Support Legal for Beta test contracts, whenever unreleased products are shipped
  • Working together with other internal functions as well as with external experts and service providers
  • Manage and lead the verification process for small to complex-scale development projects or multiple small-scale projects from project start/project prephase through project closing for upgrades, bugfixes, changes and new developments  
  • Phrase technical specifications for our product development, choose the appropriate technologies and design our products meeting all our product requirements
  • Collaborate, consult and engage with the product team to specify product requirements based on technological possibilities
  • Be the representative of the function and Inveox towards external parties (events etc.) as an industry known expert for your field
Requirements
  • Experience in the development and release of medical/ IVD devices
  • Knowledge about MDR/IVR/ISO 13485, FDA Design controls
  • Previous team lead experience
  • Regulatory exposure
  • Development and design of products (either mechanical, electrical or software)
  • Engineering or science university degree
  • Very good knowledge of English. German or Polish would be a plus!
  • Quickly adapts to changing circumstances
  • Accepts and tackles demanding goals with enthusiasm
Why inveox?
  • To the top:  At inveox, we don't see our employees as resources, but as talents! That's why we offer you many opportunities for personal and professional development 
  • Work-Life-Harmony: We support you in achieving the best performance through flexible working time models and home office option 
  • Meet & Mentor:  You will work in a highly entrepreneurial environment with experienced professionals, have the opportunity to meet renowned industry experts and receive an introduction to the German start-up scene 
  • Learn & Grow: In addition to supporting within and outside your team, you will receive regular feedback and personal coaching as well as methodical and practical training to promote your professional growth 
  • Team Spirit: Enjoy daily team lunches and poker evenings, a Christmas and summer party and lots of team events
About us
Whether it is attention to the detail of two perfectly interlocking gears or the enthusiasm with new technology to change the customer's world -everyone has its own drive. Nevertheless, we all have a desire to make Cancer diagnoses more reliable and faster, whether from personal experience or simple devotion to the underlying technology. Every day one step closer to our goal.
Your application
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