Senior Design Assurance / Quality Engineer
EPAM Continuum is looking for an exceptional Design Assurance / Quality Engineer to join its multidisciplinary team of engineers, designers, and strategists to work in our Boston office’s Technology Practice.
WHO WE ARE
EPAM Continuum is a global design and innovation consultancy that creates products, services, and experiences that work for people and the businesses that serve them. The Technology Practice focuses on innovation at the intersection of technology, engineered systems, and human-centered design. Working with companies from startup technology ventures to global manufacturers, EPAM Continuum creates technology-based products and systems that are valued by people and transform businesses.
EPAM Continuum projects span the consumer, medical, and industrial segments and include a broad range of mechanical engineering content.
WHO YOU ARE
A Design Assurance or Quality Engineer interested in joining a consultancy that works on a variety of new product development programs for electromechanical (often medical) systems. You enjoy collaborating with other engineering disciplines to manage risk and deliver high-quality systems compliant with relevant standards and regulations.
OBJECTIVES OF THE ROLE
- Assist in the implementation and maintenance of our quality system
- Engage with client leadership and client quality team to represent our quality system and ensure compatibility with the client process
- Ensure product compliance with relevant standards and regulations
- Perform product risk management activities
- Participate in the review and development of requirements and specifications
- Lead the planning, development, and execution of verification activities
SKILLS AND QUALIFICATIONS
- Bachelor’s degree in a relevant technical field
- 5+ years of experience applying design controls to medical device development
- Command of medical device quality management system directives (ISO 13485, FDA QSR)
- Risk management experience pertaining to medical device development (ISO 14971)
- Excellent written and verbal communication skills
- Demonstrated ability to collaborate effectively with varied development disciplines (e.g., mechanical engineering, electrical engineering, software engineering, human factors engineering, industrial design, interaction design)
- Experience implementing IEC 60601
- Experience implementing IEC 62304
- Demonstrated ability to support multiple projects simultaneously