Company:
Coloplast
Location: Minneapolis
Closing Date: 16/10/2024
Salary: £100 - £125 Per Annum
Hours: Full Time
Type: Permanent
Job Requirements / Description
The Interventional Urology Design Assurance Engineer is responsible for supporting new product development and commercialized 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.
- 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 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.
- Interact 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.
- Other duties may be assigned.
Basic Qualifications
- BS in Engineering (Electrical or Software Engineering preferred).
- 2+ years related experience and/or training.
- ASQ Certified Quality Engineer preferred.
- 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.
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