Manufacturing Engineer

The Manufacturing Engineer supports Interventional Urology implantable manufacturing by developing and implementing manufacturing procedures, methods, and processes that will maximize labor, material and equipment utilization while meeting regulatory requirements. 

 

Major Areas of Accountability

• 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).
• Performs 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 the purchasing, installation, and check out of new equipment.
• Plan, implement and document designed experiments to support equipment upgrades and process improvements.
• Responsible for GMP compliance of manufacturing equipment/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.
• Conform with Coloplast Code of Conduct and all local Compliance Standards.
• Conform with Coloplast Q/EHS Policy.
• Other duties as assigned.

 

Basic Qualifications

• Bachelors degree
• 3+ years of related manufacturing or relevant work experience
• Self-motivated and self-managed within a dynamic and collaborative team environment
• Strong analytical and problem-solving skills
• High performing individual that is able to accept challenges and opportunities as they arise

 

Knowledge, Skills, and Abilities

• Excellent written & oral communication skills.
• Computer skills – Microsoft Office Suite (Access, Word, Excel, PowerPoint)
• Proficient decision-making skills.
• Proficient problems solving and trouble shooting 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 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 pace 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 a