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Form of workNAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
- Act with integrity in everything we do.
- Provide best-in-class customer experiences.
- Develop superior talent and deliver expertise.
- Respond with agility and provide timely results.
- Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Provides IT leadership on projects delivering custom and purchased software systems at NAMSA and is responsible for the delivery of projects that require technical or domain understanding in area(s) relevant to the assignment.
• Provides IT leadership on complex system integration, multi-functional department and global projects.
• Leads in all phases of a project lifecycle.
• Responsible for the development, review and approval of documents as listed in the SDLC including but not limited to: user and functional requirements, business process workflows, business case development, and test scripts.
• Develop and communicate alternative approaches/solutions with others by utilizing business knowledge and business analysis best practices.
• Establish functional expertise in specified application(s) and associated business processes. Utilize this expertise to work with business users, IT management and other stakeholders to determine business objectives, feasibility and cost benefit of project requests.
• Research and understand downstream impact of application implementation/upgrade on all existing enterprise systems
• Define and lead test strategy development and documentation.
• Lead integration and end user testing.
• Translate complex concepts in ways that can be understood by a variety of audiences such as Business Owners, SME, Technical Reps and Sponsors.
• Act as an internal process improvement consultant for other internal groups looking to maximize their process, documentation and other work products surrounding project planning and requirements
• Recognizes, communicates and mitigates risks within a project.
Acts as Project Manager on small to mid-size projects, developing resource estimates, plans and proposals.
• Provides input to existing production systems and works with the IT organization and business units to provide recommendations on prioritization of support and enhancements taking into account available resources, release plans, and business value.
• Assists with problem analysis. As part of the team, ensures that technical functional specifications cover all business functional specifications.
• Participates in building and maintaining positive relationships (through expertise and influence) with internal and external customers resulting in an environment of highly effective collaboration, communication, and execution of programs/processes across the organization.
• Adheres to established SDLC processes and professional IT principles and practices.
NAMSA is committed to maintaining the security of associate, customer, supplier and public information entrusted to us. As such, NAMSA maintains an ISO27001:2013 certified Information Security Management System (ISMS). The role defined in this job description requires knowledge of and compliance with specific aspects of the NAMSA ISO27001:2013 ISMS. It is required that associates know and comply with the ISMS as defined for them in Policy, Process and SOP training.
Qualifications & Technical Competencies:
• Bachelor's degree in related discipline required
• A minimum of 5+ years of professional experience in developing, deploying, and maintaining software systems.
- MUST HAVE LIMS experience. Labware preferred but not required
• Basic technical understanding of how applications work (database structures, user interfaces, etc).
• Proven ability to engage with, manage and communicate expectations of both internal and external stakeholders.
• Ability to present business and technical concepts with Senior Level leadership team members.
• Good negation skills
• Good listener and be able to translate into requirements
• Facilitation skills
• Consulting mindset/experience
• Exceptional verbal and written communication skills.
• Experience with Global software system implementation required
• Proven skills in SDLC (waterfall and/or agile) and Testing Methodologies.
• Experience in a regulated environment is desired, specifically experience in medical device testing.
• Working knowledge of GxP guidelines preferred.
• Fluency in English is preferred.
• Deep knowledge of specific business areas and related applications, tools, and databases.
• Ability to act as the project manager for successful software implementation projects from implementation through stabilization and production.
• Proficient in the development of business process workflows (current and to be processes), business case development (cost saving, ROI), and project charter (project plan, project budget) required.
Working Conditions:
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Requires maintaining physical condition necessary for walking, standing, or sitting for prolonged periods of time.
• Extensive use of computer keyboard; operate laboratory equipment.
