3 Key Consulting, Inc. · 3 months ago
Engineer, Drug Delivery Device Complaints and Investigations (JP14565)
3 Key Consulting is recruiting an Engineer for a consulting engagement with a leading global biotechnology company. The role involves performing device assessments of complaints, authoring assessment reports, and supporting investigations related to drug delivery devices to ensure quality and optimize patient experience.
AdviceCloud ComputingInformation TechnologyStaffing Agency
Responsibilities
Perform device assessments of complaints and document results in a report
Complete evaluation and deliver assessment report on time per company requirements
Support the implementation and management of the lab infrastructure, including all equipment used for investigations
Provide requirements for lab and investigational equipment to device development teams in support of new device platforms
Support characterization testing and data gathering for investigations
Perform root cause analysis investigations for mechanical and/or electromechanical products
Qualification
Required
Technical background preferably in a GxP setting
Laboratory experience- comfort with technical testing
Strong technical writing and interpersonal skills
Master's degree and 3 years of related medical/biopharma development or Operations experience; OR Bachelor's degree and 5 years of related medical/biopharma development or Operations experience
Preferred
Master's or Bachelor's in Engineering, Science or Biomedical
2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
Experience in lab environment
Demonstrated competency in root cause analysis methodology
Experience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP)
Strong technical writing and interpersonal skills
Results-driven and detail-oriented
Strong Sense of Responsibility and Time Management
Bachelor's, Master's or PhD in Engineering, Science or Biomedical
Experience with statistics and statistical analysis
Results-driven and detail-oriented team leader
Benefits
With benefits
Company
3 Key Consulting, Inc.
3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.
H1B Sponsorship
3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)
Funding
Current Stage
Growth StageRecent News
2025-09-29
Company data provided by crunchbase