Lead the design and evaluation of courses for HyperionDev, a major edtech provider. Manage learning designers and ensure high - quality education outcomes.
About the role
- Senior Design Assurance Engineer supporting new product development and commercial products at Coloplast. Collaborating with R&D to define design inputs and outputs while managing quality standards.
Responsibilities
- 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).
- 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.
- 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.
Requirements
- BS in Engineering (Biomedical or Mechanical preferred)
- 5+ 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.
- 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%.
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, and flexible work arrangement options.
- Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
- Recognition programs to celebrate achievements and contributions.
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