Senior Systems Engineer - Medical Device Remediation

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

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