Job Description

Provides advanced technical support in the development, validation, and optimization of manufacturing processes for medical devices, ensuring compliance with regulatory and industry standards. Works closely with engineering and quality teams to implement process improvements that drive product quality, efficiency, and scalability.

Major Areas of Accountability

• Support the development and validation of manufacturing processes for medical devices in compliance with industry standards and regulatory requirements.
• Collaborate with engineering and quality teams to design and implement process improvements that enhance product quality and operational efficiency.
• Troubleshoot process deviations and defects, implementing corrective actions to maintain consistent product quality.

• Support builds for feasibility studies, design verification, and process validation activities
• Train operators on new and revised manufacturing processes
• Support Process Development Engineers in evaluation and qualification of new equipment and fixtures
• Manage inventory of raw materials and assemblies that are used for development builds
• Complete relevant tasks to fulfill major milestones, identifying key parameters and all other requirements for products
• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies.
• Other duties as assigned

Basic Qualifications

• 2-year degree or related vocational/apprenticeship or 4-6 years equivalent industry experience
• Medical Device manufacturing background preferred
• Experience working within a controlled environment
• Solid understanding of technical concepts and principles
• Effective communication skills to collaborate with cross-functional teams
• Understanding of Good Manufacturing Practices (GMP) and regulatory standards such as FDA and ISO 13485.

Required Knowledge, Skills and Abilities

• Experience with a variety of manufacturing processes, which may include automated equipment and manual processes that may require work utilizing a microscope
• Good written and verbal communication and notation skills
• Proficient in Good Documentation Practices (GDP)
• Ability to work independently
• Familiarity with Microsoft Office Products (Word, Excel, PowerPoint, etc.)
• Ability to take verbal instructions and translate them into goals and objectives
• Pro-active; high-performance and results orientation
• Ability to consistently work with ethical integrity
• Personifies Coloplast Mission, Values and Vision as well as Coloplast Leadership Principals
  
  

  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.
  • 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 starting hourly rate for this position is $30.55/hr. Hired candidates may be eligible to receive additional compensation for applicable experience and may also be eligible for bonuses and/or incentives. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location.

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 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.

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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