Lead Systems Engineer

Katalyst CRO; Bothell (WA); On-site; USD 140,000 - 180,000; Full time

Job summary

Katalyst CRO seeks an experienced medical device systems engineer to lead remediation of design control records for a portfolio of Class I/II devices. You will work onsite with the customer’s systems engineering team, own technical standards for a small team, and be the escalation point for the customer.

You will assess gaps, rebuild traceability, and defend remediation decisions during design review. Onsite three days a week in Bothell, WA, you will drive closure and ensure compliance with ISO

Qualifications

• 8+ years in medical device systems engineering with 3+ years in design control remediation or post-inspection response.
• Proficient with ISO 14971, ISO 13485, and 21 CFR 820.30.
• Experience closing FDA 483 or warning letters.
• Ability to decompose requirements and author DFMEA and Usability FMEA.
• Experience with Windchill and CodeBeamer PLM/ALM systems.
• US work authorization and onsite in Bothell three days per week.

Responsibilities

• Take ownership of gap records across requirements, risk management and verification to closed state.
• Decide remediation depth for records and defend decisions to customer managers.
• Repair and author requirements across product hierarchy retaining traceability.
• Remediate Usability FMEA and design FMEA at multiple levels with risk control linkage.
• Assess and rebuild verification evidence to support claims.
• Develop a failure-type taxonomy and propagate fixes across the portfolio.
• Run quality gates before customer review and maintain weekly status reports.
• Coordinate packaging work for offshore team and review deliverables.
• Report weekly on progress, blockers, and plan adherence.

Skills

Medical device systems engineering

Design control remediation

Traceability management

FDA 483 remediation

Education

Engineering degree (biomedical/mechanical/electrical/systems)

Tools

Windchill

CodeBeamer

ALM/PLM tools

Job description

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.