Director of Systems Engineering (NPD)
|Elmsford, New York - United States
contact recruiter for details
|15% bonus, full relo 6% 401k 4 weeks vacation
WHY IS THIS A GREAT OPPORTUNITY?
Director of Systems Engineering (New Product Development)
Elmsford, NY Or other sites available upon discussion
Competitive pay, Bonus, Excellent benefits
We have a critical opening for a Director of Systems Engineering with a global medical manufacturer; an organization dedicated to ongoing success by hiring top talent, investing in R&D, and commitment to engineering excellence for over 100+ years. This role will manage a team responsible for the integration, verification and characterization of automated medical devices to provide rapid and accurate diagnostic testing for clinical laboratories. From an engineering standpoint these medical devices rely on precision mechatronics, robotics, fluid delivery systems and thermal controls to allow for the accurate and precise reporting of patient results. This role manages a highly skilled team Managers/Engineers/Biochemists at multiple sites.
- Responsible for the integration, characterization and verification of systems for all new product development projects and activities
- Lead team’s development of systems design concepts to meet clinical chemistry and immunoassays performance requirements
- Oversee, plan, and review: team’s technical output and artifacts, design feasibility and convergence studies, subsystem and system characterization of key design space functionality and performance parameters, and development of test protocols for design verification
- Establish procedures and documentation pertaining to systems integrations, integration builds and engineering prototype configurations, design verification and traceability, design transfer, product risk management and quality of systems engineering deliverables
- Responsible for quality of deliverables to validation, manufacturing and services teams.
- Anticipate potential problems that may impact system performance and drive the development of risk mitigation plans; lead identification of solutions to complex technical issues by root cause analysis procedure and propose design modifications as they pertain to system and assay performance
- Assure team’s compliance to all integration and verification quality procedures and policies of product development
- Manage resources planning and respond in timely manner to changing business priorities with updates in overall systems integration and verification plans
- Be a people leader for a technically-focused team of systems engineers and biochemists and work closely with direct reports to guide their professional growth
- Ensure internal collaboration between the Systems engineering team and all interfacing Design Engineering and Commercial Product Engineering teams is strong
- Embrace strong team-oriented approach and drive a learning mindset
Required Knowledge/Skills, Education, and Experience
- B.S in Engineering is required. 10+ years experience in a Systems role; with at least 5+ in Management.
- Must have knowledge of medical/FDA regulated industry
- Skilled at overall complex systems thinking; with a broad range of knowledge and experience in system characterization, integration, verification and validation.
- Experience providing direction and technical guidance to a team of engineers, ideally a cross functional matrixed environment.
- Experienced in aspects of Agile and SCRUM
- Able to provide challenging tasks and assignments to the team
- Able to maintain an active dialogue regarding performance and career path.
- Effective verbal and written communication skills are essential.
- Certified SCRUM Master preferred
University - Bachelor's Degree/3-4 Year Degree