What are the responsibilities and job description for the Senior Design Risk Associate (Medical Device) position at United Pharma?
Position Summary
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
- :Risk Management Plan
- sHazard Analyse
- sRisk Assessment
- sRisk Management Report
- sRisk Traceability Documentatio
- nFacilitate and participate in
- :DFME
- APFME
- AHazard Analysi
- sRisk Review Meeting
- sEvaluate the impact of
- :Design change
- sManufacturing change
- sSupplier change
- sCAPA
- sNonconformance
- sMaintain traceability between
- :User Need
- sDesign Input
- sRisk Control
- 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
s
Required Qualificatio
- nsBachelor's degree in Engineering, Life Sciences, or related technical discipli
- ne5-10 years of medical device industry experien
- ceDemonstrated experience wit
- h:ISO 14971 Risk Manageme
- ntDFM
- EAPFM
- EAHazard Analys
- 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,
MA
Preferred 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