Manufacturing Engineer III - Sustaining

Cretex • Brooklyn Park, MN

28d

About The Position

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.

Requirements

• 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

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

Benefits

• 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.
• Cretex’s 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees