Manufacturing Engineer III Sustaining
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Job Location:
Brooklyn Park, MN - USA
Monthly Salary:
Not Disclosed
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Department:
Job Summary
Overview
About Cretex Medical
Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding laser processing metal stamping and device assembly. Learn more at .
Manufacturing EngineerIIIPosition Summary
The Manufacturing Engineer III leads the development validation and optimization of complex manufacturing processes for medical devices with a focus on plastic injection molding and assembly. This role drives design-for-manufacturability resolves high-impact technical issues mentors other engineers and ensures compliance with ISO 13485 GMP and Quality System requirements.
Responsibilities
- Lead development and implementation of new and improved manufacturing processes to support current and next-generation medical device programs
- Apply advanced engineering principles to solve complex high-risk manufacturing and quality problems including novel or non-standard solutions
- Partner with Quality Manufacturing and Supply Chain to transfer new products and processes into production
- Own and approve manufacturing documentation including routers bills of material and procedures
- Monitor and optimize equipment tooling and process performance to improve yield capability and product quality
- Design specify and implement fixtures gauges and manufacturing aids
- Lead resolution of nonconformances and actively participate in Material Review Board (MRB) activities
- Analyze and improve manufacturing processes using Lean SPC DOE and FMEA methodologies
- Support cost estimation and cost-reduction initiatives
- Mentor and technically guide Manufacturing Engineers I and II
- Ensure full compliance with ISO 13485 GMP QSR and internal Quality System requirement
Qualifications
- Bachelors degree in Mechanical Industrial or related Engineering discipline
- 5 years manufacturing engineering experience preferably in medical devices
- Demonstrated experience in process design validation (IQ/OQ/PQ) and production support
- Strong working knowledge of ISO 13485 GMP and FDA QSR
- Experience with plastic injection molding assembly processes and manufacturing automation
- Proficiency in DOE SPC FMEA and statistical analysis software
- Experience designing fixtures gauges and manufacturing equipment
- Familiarity with Lean manufacturing principles
- Proficiency in 3D CAD software (e.g. SolidWorks Creo NX)
- Strong project management communication and cross-functional leadership skills
- High level of ownership integrity attention to detail and ability to manage ambiguity and competing priorities
Pay Range
Pay Range Details
This pay range reflects the base hourly rate or annual salary for positions within this job grade based on our market-based pay structures. Actual compensation will depend on factors such as skills relevant experience education internal equity business needs and local market conditions. While the full hiring range is shared for transparency offers are rarely made at the minimum or maximum of the range.
Company Benefits
All Employees:
Our 401k retirement savings plan with a company match contribution; onsite health clinics discretionary holiday bonus program (based on years of service) Cretex University 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost wellness program with incentives an employee death benefit and employee sick and safe leave are available to all Cretex employees.
20hours:
Cretexs medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account healthcare and dependent care pre-tax reimbursement accounts; paid holidays paid time off; and our discretionary profit sharing program are available to employees working 20 hours/week.
30 hours:
Parental Leave accident and critical illness benefits optional employee spouse and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30 hours per week.
(Some benefits are subject to eligibility criteria.)
Applicants will receive consideration for employment regardless of their race color creed religion national origin sex sexual orientation gender identity disability age veteran status marital status family status status with regard to public assistance or any other protected status as required by law.
Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify including your rights and responsibilities please visit Experience:
IC
Key Skills
- Lean Manufacturing
- Six Sigma
- CNC Programming
- Lean
- Machining
- Tooling
- CAD
- CNC
- Assembly Experience
- SolidWorks
- Kaizen
- Manufacturing
