Top 4 Lead controls systems engineer Jobs in Everett Wa

Lead Systems Engineer
Katalyst Healthcares & Life Sciences —Bothell, WA
- Call employer
- Master's degree
- Team management
- US work authorization
Quick Apply
7d
Process Design Lead, Fuel Cycle
Helion —Everett, WA
- $147,000 - $182,000 a year
- Full-time
- 5 years
- Engineering
- Office
- Paid parental leave
- Paid holidays
Quick Apply
Systems B777-9 EIS FSE - Systems EIS Support Engineer (Advanced Lead Engineer)
GE Aerospace —Mukilteo, WA
- $128,800 - $171,350 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- 5 years
- Paid parental leave
- Disability insurance

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Lead Control Systems Engineer
RoviSys Building Technologies —Dublin, OH
Bachelors Degree in a technical field or related Technical Degree. Program field modifications as required. 3+ years of experience in related field/industry.
$80,000 - $130,000 a year
Lead Control Systems Engineer
RoviSys —Dublin, OH
Work in team environment with engineers and designers from RoviSys, partners and clients to provide state of the art Control Systems to improve efficiency,…
$100,000 - $125,000 a year

I want to receive the latest job alert for lead controls systems engineer in everett wa

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

lead controls systems engineer jobs near everett wa

Lead Systems Engineer

Katalyst Healthcares & Life Sciences -
Bothell, WA

Quick Apply

Job Details

Contract
7 days ago

Qualifications

Requirements specification
Requirements design
Design failure mode and effects analysis (DFMEA)
Requirements analysis
Systems engineering
Requirements management
Design usability
Design controls
Biomedical regulatory compliance
ISO 13485
FDA regulations
Product lifecycle management

Full 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.

Quick Apply

Refine Your Search

lead controls systems engineer jobs in everett wa

Lead Systems Engineer

Process Design Lead, Fuel Cycle

Systems B777-9 EIS FSE - Systems EIS Support Engineer (Advanced Lead Engineer)

Explore jobs in cities nearby

I want to receive the latest job alert for lead controls systems engineer in everett wa

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected