Senior Manufacturing Engineer
Location: Minneapolis, MN, US
Job Family: Manufacturing
Country/Region: United States
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
- 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).
- Perform 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.
- Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
- Other duties as assigned.
Basic Qualifications
- 4-year engineering degree.
- 5+ years of related manufacturing work experience. 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 that is able to accept challenges and opportunities as they arise.
- 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, 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 problems 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.
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 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.
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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.
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