Senior Design Quality Engineer
About the CompanySynergy Spine Solutions is focused on identifying and commercializing innovative spine technologies to improve patients’ quality of life and advance the standard of care. Our flagship product, the Synergy Disc, is uniquely designed to restore both motion and alignment to the spine. We are committed to providing cutting-edge solutions that help surgeons achieve better outcomes for their patients.About the RoleWe are seeking a Senior Design Quality Engineer to join our growing team. This role is responsible for ensuring quality and compliance throughout the product development lifecycle, from concept through commercialization. The ideal candidate will bring deep expertise in design controls, risk management, and quality systems within the medical device industry.ResponsibilitiesNew Product Development Team Member Responsible for R&D Quality Engineering activitiesSupport new initiatives on R&D ProjectsMaintain Design Control Phase Gates and deliverablesParticipate in design reviewsConduct Risk Analyses with Design TeamSupport Design for Manufacturability, Reliability, Usability, V&V activitiesReviewing & writing technical reports, validationsSupport Supplier Qualification activitiesSustaining Quality Support Support QMS activities including internal audits, CAPAs, and complaint investigationsHelp maintain a compliant and effective QMSMaintain and update Risk Management FilesQuality Operations Support Assist in QMS activities Qualifications5+ years of professional experience in Medical DevicesEducation: Engineering/Technical Degree Required, Mechanical PreferredProficient with Design Controls and related Regulations/Standards (ISO-13485, 21CFR820, ISO-14971, ISO-62366, EU/MDR)Must be able to read and communicate in EnglishHigh attention to detailExceptional communication skillsProblem-Solving/Critical Thinking skillsBasic reading and understanding of engineering drawingsDependable, reliableProficiency with Microsoft Office products (Word, Excel, & Office)Data Analytics capabilities in Excel, Minitab for Post Market data and statistical analysis for sample sizesAbility to work in a team environment and independently with minimal supervision Preferred SkillsExperience with Greenlight Guru QMS platformFamiliarity with Lean / Six Sigma methodologies and Design of Experiments (DOE)Prior involvement in electromechanical, mechanical, and sterile medical devicesClass III implantable device experienceReusable Instrument experience