Cretex Medical Component and Device Technologies · 1 week ago
Manufacturing Engineer III - Sustaining
Minneapolis, MN
Full-time
Onsite
Senior Level
$91K/yr - $136K/yr
5+ years expCretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. The Manufacturing Engineer III leads the development, validation, and optimization of complex manufacturing processes for medical devices, focusing on plastic injection molding and assembly.
Medical Device
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
Qualification
Required
Bachelor's 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
Benefits
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
Employee death benefit
Employee sick and safe leave
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
Pre-tax health savings account
Healthcare and dependent care pre-tax reimbursement accounts
Paid holidays
Paid time off
Discretionary profit sharing program
Parental Leave
Accident and critical illness benefits
Optional employee, spouse, and child life
Short and long term disability
Company provided life insurance
Tuition assistance programs
Company
Cretex Medical Component and Device Technologies
Our mission is to make it easier for our customers to get their products to the patients who need them.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase