Principal Manufacturing Engineer

Job Function Summary
The Principal Manufacturing Engineer supports Interventional Urology implantable manufacturing by developing and implementing manufacturing procedures, methods, equipment and processes that will maximize labor, material and 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.
• Mentor and assist lower-level engineers through projects.
• 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 job duties as assigned.

Basic Qualifications

• Bachelor's degree in engineering or related field.
• 10+ years of related manufacturing work experience.
• 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 can accept challenges and opportunities as they arise.
• History of successful project management.

Required Knowledge, Skills, and Abilities

• Advanced 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 risk assessment principles.
• Knowledge of design for manufacturing (DFM) methodologies.
• Advanced decision-making skills.
• Advanced problems solving and trouble shooting skills (preferred Six Sigma Green Belt/Black Belt certification).
• 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.

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 work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. 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 $97,499.00 - $146,249.00. 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.

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 worlds 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.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because - and not despite - of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

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