Manufacturing Engineer II, III, Sr

Posted 2 Days Ago
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Dassel, MN, USA
In-Office
75K-168K Annually
Senior level
Healthtech • Manufacturing
The Role
Leads manufacturing process development, design for manufacturability, continuous improvement, equipment and fixture implementation, process validation, and production support for medical device components and assemblies. Responsibilities include maintaining routers, bills of materials, procedures, and quality documentation; resolving equipment issues and nonconformances; supporting material review; analyzing process efficiency; estimating costs; mentoring engineers; and ensuring compliance with ISO 13485, GMP, and medical device requirements.
Summary Generated by Built In
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 www.cretexmedical.com.


Position Summary 

The Manufacturing Engineer will be responsible for leading the manufacturing of product and implementation of improvements including cost, manufacturability, and quality goals. Responsible for planning, designing, developing, and maintaining programs, training, and manufacturing processes (such machining, packaging, welding, assembly, and molding). Provide direction and support for existing products including support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes and to ensure that production goals are met.


**Role open to Manufacturing Engineer level II/III/Sr candidate based on experience**

Responsibilities
  • Initiate and complete technical activities leading to new or improved processes or design for manufacturability for current and next generation programs and to meet strategic goals and objectives of the company
  • Analyze and solve problems from basic engineering principles, theories, and concepts through to a wide range of complex and advanced problems which require novel and innovative approaches or a breakthrough technology
  • Interface with quality and manufacturing to integrate new products or processes into the existing production area
  • Maintain and approve device routers and bill of materials
  • Monitor performance of equipment, machines, and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues
  • Maintain and approve manufacturing procedures
  • Design and coordinate fabrication and implementation of process fixturing or gauging
  • Resolve non-conformances and participates on Material Review Board
  • Analyze and map processes, assesses efficiency, and implements complex project activities
  • Assist with part cost estimation
  • Mentor Engineer I and II
  • Support and comply with the company Quality System, ISO, and medical device requirements
  • Read, understand, and follow work instructions and standard work
  • Partner with other business segments:  sales/marketing, customer service, engineering, quality, and finance
  • Understand customer needs and the core business markets we serve
Qualifications
  • Bachelor’s Degree in Mechanical, Industrial, or other Engineering Science
  • Experience
    • Manufacturing Engineer II - 3 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions
    • Manufacturing Engineer III - 5 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions
    • Manufacturing Engineer Sr - 7 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions
  • Experience in an ISO13485/GMP environment
  • Engineering experience with medical devices
  • Manufacturing process design and validation
  • Manufacturing equipment and fixture/gauge design
  • Lean manufacturing experience
  • Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict)
  • DOE, SPC, FMEA, GMP, QSR
  • Knowledge of statistical software
  • Knowledge of materials and related processes
  • Project management experience
  • Manufacturing automation, including electronic visual inspection
  • 3D CAD software (i.e. ProE, Unigraphics, Solidworks, etc.)
  • Excellent communication and influencing skills
  • High level of energy, personal accountability, and integrity
  • Highly detail oriented; checks own work, keeps accurate records, organizes information effectively
  • Ability to tolerate ambiguity, multiple priorities, and short deadlines
  • Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
  • Clear and effective verbal and written communication skills
  • Attention to detail and organization skills
  • Ability to work in a fast-paced team environment, ability to multitask 

Preferred Knowledge, Skills and Abilities  

  • Continuing Education; including participation in local chapters, associations, and/or organizations

Hiring Range:

Manufacturing Engineer II:   $75,000 - $112,600

Manufacturing Engineer III:  $90,800 - $136,200

Manufacturing Engineer Sr:  $112,600 - $168,000


What is it like to work at Cretex Medical?

We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.


Here are some of things that employees have said about working for Cretex Medical:


  • “The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right.”
  • “I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.”
  • “I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.”

We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member.


#LI-MH1

Pay RangeUSD $75,000.00 - USD $168,000.00 /Yr. 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. 


20+hours:

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. 


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 www.dhs.gov/E-Verify. 

Skills Required

  • Bachelor's degree in Mechanical Engineering, Industrial Engineering, or another engineering science
  • Manufacturing Engineer II: 3 years of engineering experience in a manufacturing setting
  • Manufacturing Engineer III: 5 years of engineering experience in a manufacturing setting
  • Senior Manufacturing Engineer: 7 years of engineering experience in a manufacturing setting
  • Experience with state-of-the-art manufacturing technology, concepts, and cost reductions
  • Experience in an ISO 13485 and GMP environment
  • Engineering experience with medical devices
  • Manufacturing process design and validation experience
  • Manufacturing equipment and fixture or gauge design experience
  • Lean manufacturing experience
  • Team communication, accountability, decision-making, feedback, meeting management, and conflict management skills
  • Knowledge of DOE, SPC, FMEA, GMP, and QSR
  • Knowledge of statistical software
  • Knowledge of materials and related manufacturing processes
  • Project management experience
  • Experience with manufacturing automation, including electronic visual inspection
  • Experience with 3D CAD software such as ProE, Unigraphics, or SolidWorks
  • Excellent communication and influencing skills
  • High energy, personal accountability, and integrity
  • Strong attention to detail, recordkeeping, organization, multitasking, and ability to work under short deadlines
  • Microsoft Office proficiency, including Outlook, Word, Excel, PowerPoint, and Publisher
  • Ability to work effectively in a fast-paced team environment
  • Continuing education and participation in local chapters, associations, or organizations
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The Company
2,200 Employees
Year Founded: 2023

What We Do

Cretex Medical is a family of operating companies providing end-to-end manufacturing and engineering services to medical device OEMs. Its capabilities span high-precision components and assemblies, laser processing, injection molding, metal stamping, precision machining, finished-device assembly, packaging, cleaning, and sterilization validation. The company helps customers progress from individual components to complete sterile medical devices ready for critical procedures and patient care.

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