Senior Design Risk Associate (Medical Device)

We are seeking a Design Risk Associate to support a large-scale medical device remediation and compliance program. This role will focus on the execution and maintenance of product risk management activities within a regulated medical device environment. The ideal candidate will have 5-10 years of medical device experience supporting risk management, design controls, and product development activities, with hands‑on experience applying ISO 14971 throughout the product lifecycle. Responsibilitie sSupport risk management activities for Class II and Class III medical device sAuthor, update, and maintain sRisk Traceability Documentatio nFacilitate and participate in

:DFME

APFME

sEvaluate the impact of :Design change sManufacturing change sCAPA sNonconformance sMaintain traceability between :User Need sDesign Input sVerification Activitie sValidation Activitie sSupport Design History File (DHF) remediation and Design Control initiative sCollaborate with Quality, Engineering, Regulatory Affairs, and Manufacturing teams to ensure risk documentation remains compliant and inspection-read ySupport internal and external audit readiness activitie sRequired Qualificatio nsBachelor's degree in Engineering, Life Sciences, or related technical discipli ne5-10 years of medical device industry experien ceDemonstrated experience wit ntDFM

EAPFM

isDesign Contro lsDHF Documentati onWorking knowledge o f:FDA 21 CFR Part 8

20ISO 134

85Medical Device Product Development Process esStrong technical writing and documentation skil lsAbility to work onsite in Danvers, MAPreferred Qualificati onsExperience supporting remediation programs, FDA observations, or quality system improvement initiati vesExperience with EU MDR risk management requireme ntsExperience supporting Class III medical devi cesBackground in Design Assurance, Systems Engineering, or Product Quality Engineer #J-18808-Ljbffr United Pharma