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.
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- 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.
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- 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 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.
At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:
- Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
- Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
- Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
- Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
- Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
- Community and Culture: A supportive and inclusive work environment where everyone feels valued, and diversity is celebrated. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Employee Resource Groups that support Women, Minorities, Veterans and LGBTQ+ Community. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
- Competitive Compensation: The compensation range for this position is $78,882 - $118,323. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.
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