R&D Manager and Senior Project Manager

ITERON AG in Basel area

2020-10-07

Contact


Function

IT / Internet
Software developer, Full time

Offering Equity

No

Salary

CHF 130000 - CHF 150000

We are looking for R&D Manager cum Senior Project Manager to support our medical device client from our office in Basel, Switzerland and requires about 10% travel to client location on a weekly basis. Job Responsibilities • Overview the FMEA team (DCRM-Design clinical risk management and PRM-Production Risk management) and provide the necessary technical support in getting the deliverables completed. • Analyse and evaluate clinical data gathered and ensure compliance with regulations. • Responsible for shared service document review, specially to Restricted substances report and Biocompatibility report and comply with regulatory standards. • Systematic review of different DHF’s for the Product line • Ensure accurate risk benefit analysis cascaded in documents and get reviewed by medical affairs • Good Experience in Plastic and metal part design, material ion • Proven track record in R&D functions is a must have • Previous experience working for a global medical device company and good understandings in ISO 13485 and EU MDR Regulation (EU) 2017/745 • Ensure accurate activity or study budget management, updates for scope changes and reconciliation of assigned studies for out of pocket expense and FTE costs. • Tracking budgeting and invoicing, working with purchase order preparer Qualifications: • At least 5 years of technical experience and minimum 3 years management experience is must • Relevant working experience with Mechanical Engineering background is added advantage • Experience in materials and Plastics and Proficiency in Plastic and metal part design (Proficient with plastic and metal part design, material ion, assembly/machine design, 3D modelling/surfacing of parts/assemblies in CAD software, creation of 2D and process drawings for quoting and material procurement) • Proven management experience in an Orthopaedic industry • Good analytical skill, ability to prioritize and plan the multiple tasks. • Good problem solver and negotiator • English fluency and German knowledge are expected

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