Design Assurance Manager
Nextern, a medical device design and manufacturer, is seeking a Design Assurance Manager. Nextern focuses on medical devices in markets utilizing endovascular therapy delivery and electro-mechanical integrated systems.
Be a key contributor to the Nextern product realization team, a talented group of dedicated engineering professionals who work together to solve problems, reach goals and deliver products that exceed customer expectations. Join an organization with a passion for creating smart, intuitive and effective medical products.
The Design Assurance Manager utilizes risk management, quality planning, and product test disciplines and techniques to provide quality engineering, assurance, and control support of medical device design and development projects. The Design Assurance Manager independently leads departmental or cross-functional design assurance initiatives and effectively leads the standardization and continuous improvement of quality based disciplines, decisions and practices employed in the product realization business processes at Nextern. The Design Assurance Manager will effectively partner with the development engineering organization in creating a highly efficient, scalable medical device product development processes to enable Nextern's business goals and customer partnerships.
DUTIES AND RESPONSIBILITIES:
- Manage staffing and performance management of Design Assurance work group at Nextern's White Bear Lake facility.
- Establish standard work processes for Design Assurance activities in support of Nextern's medical device development business.
- Collaborate with development engineering work group to establish compliant, agile, and scalable product development business processes, techniques, and tools.
- Performs other related duties as assigned by management.
- Bachelor’s degree or higher in engineering or STEM discipline from an accredited university, plus 8+ years of relevant experience in medical device design assurance and product development. Relevant experience should align directly to the job specific responsibilities listed below.
- Experience managing medical device product development projects with cross-discipline team.
- Experience with validation of medical device software (SaMD) products.
- Experience with product realization business processes compliant to Quality Systems standards outlined in CFR 820/ ISO 13485
- Experience deploying Risk Management processes as outlined in ISO 14971, ISO 13485, and/or IEC 62304
- Experience in testing medical device products from system requirements to design verification testing processes.
- 2+ Years of Managerial Experience
- Must have experience working within the requirements of: IEC 62304, ISO 62366, and IEC 60601
- Demonstrated technical expertise and leadership in design quality assurance
- Strong ability to communicate (written and verbally) within and across disciplines and organizational structures
- Demonstrated use of Quality tools and methodologies
- High attention to detail, organization and accuracy
- Fitness Center Subsidy