Design Assurance Manager, IS

Nextern•Maple Grove, MN

About The Position

Join Nextern’s growing engineering team as a Design Assurance Manager and play a key role in guiding the quality and reliability of innovative medical technologies. In this role, you will mentor and lead Design Assurance and Test Engineers while helping shape the strategic direction of requirements management, verification, and quality system processes. Working cross-functionally with engineering, quality, and manufacturing teams, you will support product development programs from concept through commercialization. If you enjoy solving complex technical challenges while building strong teams and processes, this is an exciting opportunity to make a meaningful impact.

Requirements

Bachelor’s in Life Science discipline or equivalent combination of education and experience.
5+ years of experience in a quality role within a medical device development environment
3+ years of experience in a people or technical leadership role
Demonstration of strong technical writing skills in all job responsibilities
Strong leadership skills to motivate and enable department employees to meet objectives
Ability to work in a highly matrixed and geographically diverse business environment.
Adaptability to work effectively within a team in a fast-paced, changing environment.
Strong organizational, planning, and follow-up skills to ensure accountability
Demonstrated capability for effective collaboration and alignment across departments
Strong written and verbal communication skills to effectively communicate at all levels in the organization
Ability to set goals and provide constructive feedback to enhance relationships and improve business results
Aptitude for Change Leadership, working effectively within a team in a fast-paced environment
Intermediate to advanced proficiency with MS Office Suite (Word, Excel, PowerPoint, Project, Outlook)
Direct experience in Quality functions for medical device product development, manufacturing, post-market surveillance, and QMS monitoring
Direct experience with medical device capital equipment and/or systems, including, but not limited to: requirements management, software qualification, regression analysis, V&V, DFM, and electrical safety standards (e.g. IEC 60601-1)
Proficiency in reviewing, reading, analyzing, and interpreting general business periodicals, professional journals, technical procedures, and governmental regulations
Expert in writing reports, business correspondence, and procedure manuals

Nice To Haves

Experience working in a broader enterprise/cross division business unit model preferred

Responsibilities

Responsible for the individual contribution, supervision, and development of their team
Define and communicate objectives for the department linked to organizational goals/vision
Lead employees in driving continuous improvement in department owned processes
Provide routine communications with cross functional peers to assure awareness
Provide timely performance & developmental evaluations of department staff
Direct project assignments for engineers & technicians.
Prospectively identify resource needs; recruit, interview, hire, and onboard candidates
Work cross functionally in identifying and resolving technical issues
Build strategic partnerships with internal and external stakeholders
Demonstrates effective change leadership.
Review, analyze, and present Quality System metrics to senior staff
Communicate quality policies, strategies, and procedures to the organization
Own, collaborate, and drive changes to QMS based on monitored performance and regulatory landscape
Identify opportunities to proactively assure compliance to all applicable internal, domestic, and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc…
Identify and drive opportunities for risk reduction, cost improvement, and budgetary responsibility
Adheres to all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
Directly supervises employees within the quality department(s)
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws
Interview, hire, train, and support employees; assign and direct work aligned with competency
Ensure adequate resources to complete Quality objectives and maintain regulatory compliance
Assess, develop, and appraise employee capability and performance to assure effective support