Coloplast is a leading medical device company that develops and markets products and services for intimate healthcare needs. The Interventional Urology Design Assurance Engineer will support new product development and ensure compliance with design controls and regulatory standards.
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.
Review and support Electrical and Software Design Inputs, Design Verification and Test Readiness Reviews.
Work with R&D team and 3rd party software/electrical consultants to complete project deliverables
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 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 Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
Other job duties as assigned.
Qualification
Required
BS in Engineering (Electrical or Software Engineering preferred)
2+ years related experience and/or training
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%
Preferred
ASQ Certified Quality Engineer preferred
Benefits
Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy.
Access to company sponsored wellness programs and mental health resources.
Paid leave of absence for qualifying events.
Generous paid parental leave for both birthing and non-birthing parents.
A competitive 401(k) plan with company match that vest immediately.
Financial planning services to help you secure your future.
Corporate discount programs for goods and services.
Generous paid time off.
Flexible work hours.
Flexible work arrangement options to help you balance your personal and professional life may be available.
Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
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.
Coloplast is a manufacturer of medical devices that offers ostomy, continence, and wound care products.
