Grifols Shared Services North America, Inc Sr. Systems Engineer in San Diego, California
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
The Senior Systems Engineer in the Systems Engineering team shall develop and support in-vitro diagnostics (IVD) systems comprising of software, instrumentation hardware and assays; participating as a development lead in cross-functional project teams. He/she shall work as a subject matter expert, planning and carrying out development activities and solving in-depth and cross-functional problems and/or scientific/technical challenges by utilizing expertise in systems engineering and integration of software, hardware, and assays.
Primary responsibilities for role:
Lead development of IVD systems, from requirements through design and implementation, through validation and to customers.
Contribute to the architecture of systems solutions.
Contribute to the drafting and review of development agreements with outside partners and vendors.
Oversee outside partners and vendors work and progress towards developing IVD system products, including prototype testing, defect reviews, design reviews, V&V
Work with Global Marketing in the development of customer requirements, and develops product requirements using requirement management methodologies, including change management.
Work with internal stakeholders to facilitate the collection of business and regulatory requirements.
Develop system level product requirements and component requirement documents.
Conduct patient safety risk management activities according to FDA and ISO regulations.
Define and prepare a schedule of systems engineering and development tasks.
Plans and performs feasiility evaluations, engineering studies, and system, integration and unit testing.
Support verification and validation activities.
Apply working knowledge of network connectivity and cybersecurity requirements for IVD and clinical diagnostic products.
Document and present work product to project team and business stakeholders
Contribute to improving SOPs related to systems engineering, product development and design control.
Mentor others in systems engineering best practices.
May be responsible for leading and/or managing other systems experts.
Knowledge, Skills, and Abilities:
B.S. Degree in Engineering and/or Science: advanced degree preferred.
5+ years of relevant experience developing IVD integrated system based diagnostic products.
Experience with leading development efforts in a cross functional environment
Ability to solve complex systems issues and problems
Experience with Laboratory Information Systems (LIS) is a plus
Demonstrated software product development experience, using lifecycle methodologies.
Strong knowledge of best practices of development under FDA design control.
Possesses project leadership skills in managing priorities, delegating, and influencing others.
Ability to convey very complex information in both written and oral form.
Experience with managing external vendor relationships.
Ability to influence others, gain acceptance and build consensus.
Strong written and oral communication skills.
Knowledge of molecular biology is a plus.
B.S/B.E. or graduate degree in Engineering or Biotechnology or equivalent disciplines.
B.S/B.E. 6+ yrs or MS /ME 4+ yrs
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home