Senior Manufacturing Engineer

2 weeks ago

Minneapolis, Minnesota, United States Coloplast Full time
Job Title: Senior Manufacturing Engineer

The Senior Manufacturing Engineer plays a critical role in supporting the development and implementation of manufacturing procedures, methods, and processes that maximize labor, material, and equipment utilization while meeting regulatory requirements.

Key Responsibilities:
  • Identify and justify opportunities for implementing equipment upgrades, process improvements, and continuous improvement activities and initiatives.
  • Perform equipment, process, and product performance qualifications and validations, including risk assessments.
  • Conduct statistical analysis and report results in a technical protocol/report conforming to FDA standards.
  • Conduct root cause analyses and provide resolution of manufacturing issues.
  • Manage projects, including capital expenditures, to schedule and within budget.
  • Perform all necessary functions from purchasing, installation, and checkout of new equipment.
  • Plan, implement, and document designed experiments to support equipment upgrades and process improvements.
  • Ensure GMP compliance of manufacturing equipment and processes.
  • Support maintenance activities via utilization of engineering and technical knowledge/skill set.
  • Document new and existing procedures as they relate to the manufacturing process.
Requirements:
  • 4-year engineering degree.
  • 5+ years of related manufacturing work experience, with electronics experience preferred.
  • 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 able to accept challenges and opportunities as they arise.
  • History of successful project management.
Knowledge, Skills, and Abilities:
  • Excellent written and oral communication skills.
  • Advanced computer skills - Microsoft Office Suite (Access, Word, Excel, PowerPoint), Minitab, SolidWorks, etc.
  • Knowledge and capabilities in fabrication and design of mechanical parts, tools, and assemblies.
  • Knowledge of design for manufacturing (DFM) methodologies.
  • Proficient decision-making skills.
  • Proficient problem-solving and troubleshooting skills.
  • Ability to effectively interact with various internal and external customers/vendors.
  • Ability to convey a positive and professional image to internal and external customers.
  • Ability to apply multi-disciplined problem-solving approaches to production and quality problems.
  • Ability to exercise sound judgment to resolve manufacturing issues.
  • Ability to work independently and with team members.
  • Ability to multi-task and prioritize multiple projects.
  • Ability to work in a fast-paced dynamic environment.
  • Ability to communicate and train cross-functionally at every level of the business.
Environmental Health and Safety Responsibilities:
  • Seek environmental, health, and safety opportunities and make appropriate recommendations.
  • Comply with corporate standards for environment, health, and safety.
  • Reduce impacts on environment, health, and safety by systematically optimizing daily operations.

Coloplast is a leading medical device company that develops and markets products and services that make life easier for people with intimate healthcare needs. We are committed to a policy of Equal Employment Opportunity (EEO) and employ 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.

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