Job Description:
You will 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.
Responsibilities:
You will 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.
Responsibilities:
- 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.
- 8+ years in 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.
- Worked a live FDA 483 or warning letter remediation and can describe what you personally closed.
- Fluent in ISO 14971, ISO 13485, and 21 CFR 820.30
- Decompose requirements, author DFMEA and Usability FMEA, and design verification protocols without supervision.
- Worked in a PLM and an ALM environment. Windchill, Codebeamer are the toolchain here; equivalents are acceptable with a short ramp.
- You hold your position in a room. You will be the senior Client's engineer in a customer design review, and you will be asked to justify decisions on the spot.
- Bachelor's or Master's in biomedical, mechanical, electrical or systems engineering.
- US work authorization and can be onsite in Bothell three days a week.