Senior Design Assurance Engineer

The Interventional Urology Senior Design Assurance Engineer is responsible for supporting new product development and commercial products.

Major Areas of Accountability

• Participate in New Product Development Phase Reviews; lead/participate in Design Reviews.
• Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
• Ensure relevant design standards are appropriately applied and satisfied. Create and support the development and validation of new test methods.
• Determine and document risks (Hazard Analysis, DFMEA, PFMEA, UFMEA).
• Support the execution of design verification and validation, as well as usability.
• Generate/support test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing, including shelf life and stability.
• Drive improvement of Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency.
• Support regulatory approvals and responses to regulatory questions.

• Manage the stability test program

• Support and execute design and process changes to commercialized product.
• Support the transfer of new product development projects from development to production.
• Support internal and external audits.

• Manage statistical support for test method validations, sample size requirements, etc.
• Interacts with external contract manufacturers and suppliers
• Provide technical support based on overall project plans with the development of products in compliance with design controls, international standards, and FDA or other regulatory body guidelines.
• Manage product stability program to ensure all products have adequate heat-age and real-time aging for support of shelf life.  

• 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 job duties as assigned

 

Basic Qualifications

• BS in Engineering (Biomedical or Mechanical preferred)
• 5+ years related experience and/or training
• ASQ Certified Quality Engineer preferred

 

Competencies

• Ability to work independently and with general direction.
• Ability to define, organize, and manage individual and team based tasks.
• Provide direction to extended team members.
• Good written and verbal communication, with strong technical writing skills.
• Understanding of design controls, risk management, statistics, test method validation, and new product development processes.
• Knowledge and application of FDA, QSR, ISO 13485 and ISO 14971 requirements.
• Structured and methodical problem-solving approach.
• Ability to travel up to 10%.
• Personifies and fosters the Coloplast Mission, Vision and Values.

 

 

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: R