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.

• 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

• ns Bachelor's degree in Engineering, Life Sciences, or related technical discipli
• ne5-10 years of medical device industry experien
• ce Demonstrated experience wit
• ntDFM
• EAPFM
• is Design Contro
• lsDHF Documentati
• on Working knowledge o
• f:
  
  FDA 21 CFR Part 8
• 20
  
  ISO 134
• 85
  
  Medical Device Product Development Process
• es Strong technical writing and documentation skil
• ls Ability to work onsite in Danvers,

• ons Experience supporting remediation programs, FDA observations, or quality system improvement initiati
• ves Experience with EU MDR risk management requireme
• nts Experience supporting Class III medical devi
• ces Background in Design Assurance, Systems Engineering, or Product Quality Engineer