ACL Digital · 21 hours ago
Engineer/Complaints Investigation
ACL Digital is seeking an Engineer specializing in Complaints Investigation. The role involves assessing complaint samples, authoring assessment reports, and supporting investigations in a lab environment, while maintaining close interaction with the quality complaints owner.
Responsibilities
Perform device assessments of complaints and document results in a report
Complete evaluation and deliver assessment report on time per Amgen 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
Master's or Bachelor's in Engineering, Electrical, Mechanical or Science
Experience in lab environment
Strong technical writing and interpersonal skills
Master's degree; OR
Bachelor's degree and 2 years of related exp in engineering - Electrical, Mechanical, medical/biopharma development or Operations experience; OR
Associate degree and 6 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
Company
ACL Digital
ACL Digital is a design-led digital engineering and transformation firm.
H1B Sponsorship
ACL Digital 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
2025 (38)
2024 (29)
2023 (26)
2022 (33)
2021 (20)
2020 (19)
Funding
Current Stage
Late StageRecent News
2025-11-28
Precedence Research
2025-11-28
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