Edwards Lifesciences Staff Engineer Clinical Development - Forecasted Opportunity in Irvine, California
This position has been posted in anticipation for future openings within Clinical Research. We anticipate hiring a Staff level Engineer Clinical Development. If you meet the minimum job requirements, you will receive additional information about our Clinical Affairs Talent Community. .
Essential Job Functions/Key Responsibilities:
Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.
• Identify and ensure implementation of opportunities to optimize/improve beating heart simulation models for next-generation device testing employing technical design skills to re-design/design of equipment, tools, fixtures, etc. are up to standards
• Develop complex experiments and tests (including writing and executing protocols) to qualify and validate testing models processes; analyze results, make recommendations, and develop reports
• Analyze and resolve complex Clinical and Technical issues
• Develop training and documentation materials (e.g., work instructions) for the procedure based off of testing
• Lead and establish project plans to ensure deliverables are completed to customer expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
• Oversee R&D support tasks; give instruction to technicians/engineers on conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work.
Lead data analysis and derive conclusions to steer test method development and refinement
Develop project plans independently & provide guidance to assess technology and drive project results
Works independently while exercising considerable latitude in making significant decisions
Other incidental duties assigned by Leadership
Bachelors' Degree in Engineering or Scientific field required with six years' experience including either industry or industry/education required
Masters' Degree or equivalent in Engineering or Scientific field with, five years' experience including either industry or industry/education Required or
Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education Required
Additional Talents and General Expectations:
• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Strong understanding of statistical techniques
• Strong Test Method development experience
• Previous experience working with lab/industrial equipment required (if applicable)
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial knowledge of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of applicable FDA regulations for the medical device industry
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
- Excellent interpersonal relationship skills including negotiating and relationship management skills
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.