Senior Design Risk Associate (Medical Device)

United Pharma; Danvers (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

United Pharma in Danvers, MA seeks a Design Risk Associate to support a large-scale medical device remediation and compliance program. The role focuses on 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 ISO 14971 application throughout the product lifecycle.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• 5-10 years of medical device industry experience.
• Demonstrated experience with design controls and risk management.
• Working knowledge of FDA regulations and ISO 13485.
• Strong technical writing and documentation skills.

Responsibilities

• Support risk management activities for Class II and Class III medical devices.
• Author, update, and maintain risk documentation and traceability.
• Maintain Design History File (DHF) remediation and design controls initiatives.
• Collaborate with Quality, Engineering, Regulatory Affairs, and Manufacturing to ensure compliance.
• Support internal and external audit readiness activities.

Skills

Risk Management

Design Controls

Technical Writing

ISO 14971

FDA Regulations

Education

Bachelor's degree in Engineering or Life Sciences

Tools

DFME

APFME

DFM

FDA 21 CFR Part 820

Job description

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