Senior Manufacturing Engineer

The Senior 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

• Manage and direct maintenance personnel and activities.
• Identify and justify opportunities for implementing equipment upgrades and process improvements.
• 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 cGMP compliance of manufacturing equipment/processes.
• Support maintenance activities via utilization of engineering and technical knowledge / skill set.
• Support Continuous Improvement activities and initiatives.
• Document new and existing procedures as they relate to the manufacturing process.
• Perform equipment, IT systems, process and product performance qualifications and validations (including risk assessments).
• Performs statistical analysis (in some cases, complex) with trial data and report results in a technical protocol/report conforming to FDA standards.
• Determine root cause and provide resolution of manufacturing issues.
• Conform with Coloplast Code of Conduct and all local Compliance Standards.
• Conform with Coloplast Q/EHS Policy.
• Other duties as assigned.

Basic Qualifications

• 4-year engineering degree, mechanical engineering is required.
• 5+ years of related manufacturing work 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 that is able to accept challenges and opportunities as they arise.
• Experience working in a high product mix manufacturing environment.
• History of successful project management.

Knowledge, Skills, and Abilities

• Excellent written & oral communication skills.
• Advanced computer skills – Microsoft Office Suite (Access, Word, Excel, PowerPoint), Minitab, Lotus Notes, AutoCad, etc
• Knowledge and capabilities in fabrication and design of mechanical parts, tools and assemblies.
• Knowledgeable in the operation of equipment utilized in a machine shop (lathes, presses, plasma cutting, welding, etc).
• Knowledge of design for manufacturing (DFM) methodologies
• 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 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 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 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.