Job ID: BEC007475
Beckman Coulter Diagnostics helps healthcare and laboratory professionals provide better patient care by delivering the accurate diagnostic information they need, when they need it. For over 80 years, Beckman Coulter has been the partner of choice for healthcare organizations. Our scalable instruments, comprehensive diagnostic tests and business management services are trusted by hospitals, laboratories and other critical care settings around the world. We share in our customers' mission toward continuous improvement and quality patient care because we believe when efficiency and clinical outcomes are improved, patients benefit and we can move healthcare forward for every person.
Beckman Coulter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
We are looking for a dynamic Systems Integration Manager to join our team! The ideal candidate will be an experienced systems engineer who is seeking an exciting product development opportunity where the primary responsibility will be to bring engineering development experience to our diagnostic line engineering team.
The primary responsibility for this position is to lead our ongoing development program for the next generation IVD platforms, as well as provide resource support for legacy product portfolios. The Systems Integration Manager will be a critical team member working cross-functionally on programs developing new products, and in supporting legacy instrumentation in cost reduction, product design changes due to regulatory and environmental standard revisions, and customer driven product enhancements.
- Manage the day-to-day execution of work by teams and team members through monitoring progress, providing technical direction, and problem solving solutions.
- Mentor direct reports in all aspects of systems engineering and engineering career development.
- Supervise Team Leads and team members providing goals, feedback and recognition and developing bench strength through career planning and progression. Actively demonstrate Performance Management of resources to optimize skills and capabilities.
- Responsible for systems input and output requirements
- Responsible for system architectures and features
- Responsible for system overall operation/ sequence cycles
- Responsible for systems meet performance requirements
- Responsible for modules, subsystems, system integration
- Responsible for supporting manufacturing transfer prior to product launch
- Deliver key milestones per program schedule in various prototype phases
- Support lab set up and maintenance
- Responsible for mentor and knowledge transfer for Systems Integration team
- Support New Product Development and Innovation tasks for Urinalysis R&D
- Support sustaining tasks on legacy urinalysis systems
- Support CAPA and other issues relate to systems
- Support maintain development instrument for 510K data collection
- Define requirements and contribute to prototype development
- Analyze system requirements and relationships with component specifications
- Develop system Integration strategy and plans
- Develop test plans and perform (bench and system level) tests that cover the expected customer use environment and operational conditions
- Analyze, summarize, present, and interpret experimental data to formulate conclusions and make recommendations
- Work effectively with diverse teams to develop goals and plans, resolve problems, achieve goals, and coordinate efforts within and across departments.
- Bachelor’s degree in Electrical, Mechanical, Biomedical, Systems Engineering (or equivalent) with 15+ years of experience, OR Master’s degree with 7+ years of experience OR Doctoral degree with 4+ years of experience, or an equivalent combination of education and experience to perform at this level
- Prior management experience – highly preferred
- Proven track of record in launching products and delivering key milestones
- Proficient knowledge in various engineering fields (ME, EE, Systems, Optics, Fluidics, and Imaging Algorithm, etc)
- Extensive experience in developing large, complex medical devices or diagnostics instruments
- Deep understanding of customer requirements and product development requirements.
- Excellent planning, coordination, problem solving and troubleshooting skills
- Experience with FMEA (Failure Modes and Effects Analysis) as a tool to drive quality and manage risk
- Self-starter with a sense of urgency to resolve issues and complete tasks
- Previous experience with hands on testing of electromechanical subassemblies using motion control
- Prior experience in systems configuration management – highly desired.
- Prior experience in quantifying, planning and enhancing system reliability – desired.
- Prior working experience in an FDA-regulated environment, especially in IVD industry – highly desired.
- Prior experience in developing urinalysis, hematology, clinical chemistry, immunoassay, and other IVD instrumentation – desired
- Prior experience in program / project management a plus
- Proven ability to promote a culture of teamwork and willingness to roll up their sleeves to get the job done
- History of driving project execution and timely delivery while ensuring a quality focus
- Ability to make difficult decisions during various product development phases
- Ability to work in a fast-paced, and often ambiguous environment where continuous improvement is a way of life
- Must possess strong verbal and written communication skills
- Able to work independently and on cross-functional teams with development groups at other facilities as well as take work direction and follow procedures