Job Title: Systems Engineer ( Design Control Remediation)
Description:
--Lead the remediation of design control records across a portfolio of released Class I and II medical devices, working onsite alongside the customer's systems engineering team. This is post-inspection remediation work.
--The requirements, risk and verification chain has gaps. You will find them, close them, and prove they are closed.
--This is not a documentation exercise.
--The engineering judgement is the job deciding how deep a fix has to go, and knowing when a record needs rebuilding rather than patching. You will own the technical standard for a small team, and you will be the person the customer escalates to.
Your role:
--Take ownership of assigned gap records across requirements, risk management and verification, and drive each one to a closed, approvable state.
--Make the remediation depth call on every record spot cleanup, targeted rework, or full reconstruction and defend that call to the customer's systems engineering manager.
--Repair and author requirements across the full product hierarchy, restoring upstream and downstream traceability that has been lost or never established.
--Remediate Usability FMEA and design FMEA at product, element and part level, linking every risk control back to the requirement that implements it.
--Assess and rebuild verification evidence where the existing record does not support the claim being made.
--Build and own a failure-type taxonomy: classify each gap to a pattern, author the fix once, and propagate it across the portfolio rather than solving the same problem repeatedly.
--Run a quality gate before anything reaches customer review. First-pass approval rate is the metric that protects the schedule.
--Package work for an offshore support team, define acceptance criteria, and review everything they return before it is submitted.
--Report weekly in one page: closed, in review, blocked, progress against plan. Same format every week.
You're the right fit if:
--You have medical device systems engineering, with at least 3 years in design control remediation, design assurance or post-inspection response.
--Defined and managed system requirements throughout the product development lifecycle, ensuring complete traceability from user needs to verification and validation.
--You have worked a live FDA 483 or warning letter remediation and can describe what you personally closed.
--You are fluent in ISO 14971, ISO 13485, and 21 CFR 820.30
--You can decompose requirements, author DFMEA and Usability FMEA, and design verification protocols without supervision.
--You have worked in a PLM and an ALM environment. Windchill, Codebeamer are the toolchain here; equivalents are acceptable with a short ramp.
--You hold a Bachelor's or Master's in biomedical, mechanical, electrical or systems engineering
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