Lead Systems Engineer

JobDiva, Inc.; Bothell (WA); Vor Ort; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

JobDiva, Inc. seeks an experienced medical device systems engineer to lead remediation of design control records across a portfolio of released Class I and II devices. You will work onsite with the customer's systems engineering team to close gaps in requirements, risk, and verification after inspections.

You will decide the depth of remediation, own the technical standard for a small team, and be the go-to engineer the customer escalates to during design reviews and critical decisions.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Medical device systems engineering

Design control remediation

FDA remediation

PLM/ALM tools

Traceability

Onsite collaboration

Ausbildung

BS/MS in engineering

Tools

Windchill

Codebeamer

Jobbeschreibung

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

• 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.

Requirements

• 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.