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Manufacturing Engineer (Interventional Urology)

Location: 

Minneapolis, US

Job Family:  Manufacturing
Country/Region:  United States
Manufacturing Engineer (Interventional Urology) 

Coloplast has an exciting opportunity for a Sr. Manufacturing Engineer to join our growing Interventional Urology team.

 

This position will learn, develop, refine, and scale manufacturing processes for Class III active implantable medical devices and ancillaries.  The role will support outsourcing or insourcing of key processes as well as suggest, design, and implement equipment, material and process improvements related to device manufacturing. 

 

Major Areas of Accountability

 

  • Design efficient and high-quality manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, scalability, and material handling.
  • Develop and perform equipment, process and product performance qualifications and validations (including risk assessments).
  • Plan and execute line transfer of manufacturing technologies in a timely manner.
  • Identify and justify opportunities for implementing new equipment/upgrades and process improvements internally and at contract manufacturers to optimize yield, quality, cycle time and ergonomics.
  • Perform all necessary functions from the purchasing, installation, and qualification of new equipment.
  • Work with Research & Development teams to assess and provide input to projects to ensure successful transfer to manufacturing, ensuring the introduction of capable and efficient processes.
  • Develop and document new and existing process controls for manufacturing processes at suppliers and internally.
  • Support company goals and objectives, policies and procedures, cGMP and FDA regulations by working within and maintaining ISO 13485 systems.
  • Provide technical support in root cause analysis activities to resolve manufacturing issues.
  • Conform with Coloplast Code of Conduct and all local Compliance Standards
  • Conform with Coloplast Q/EHS Policy
  • Other duties as assigned

 

Essential Qualifications

  • Bachelor’s degree in Engineering, Mechanical, Industrial or Manufacturing preferred
  • 3+ years of related manufacturing or relevant work experience in hermetic Class III implantable products, experience in specific processes including assembly, laser welding of hermetic assemblies, and leak testing is preferred
  • 2+ years in medical device industry including experience with IQ, OQ and PQ activities
  • Self-motivated and self-managed within a dynamic and collaborative team environment
  • Strong analytical and problem-solving skills, including the use of statistical analysis and continuous improvement methodologies / best practices
  • High performing individual that can accept challenges and opportunities as they arise
  • Able to travel to suppliers/contract manufacturers up to 20%

 

Knowledge, Skills, and Abilities

  • Good skills in process mapping, validation, time studies and data analysis
  • Strong technical acumen with demonstrated ability to make process improvements
  • Excellent written & oral communication skills
  • Proficient in Microsoft Office Suite (Access, Word, Excel, PowerPoint), Minitab, ERP systems, etc.
  • Thorough understanding and experience using Lean and Six-Sigma principles and tools
  • Good organizational skills
  • Ability to effectively interact with various internal and external customers/ suppliers
  • Ability to multi-task and prioritize multiple projects
  • Ability to work in a fast pace dynamic environment, both independently and as a team member
  • Willingness to train manufacturing personnel on manufacturing related procedures and processes.

 

 

 

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

 

Visit us on Coloplast.com.

Watch the film. Follow us on LinkedIn. Like us on Facebook.

 

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

 


Nearest Major Market: Minneapolis

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