Katalyst CRO · 6 hours ago
R&D Design Engineer
Irvine, CA
Contract
Onsite
Mid LevelKatalyst Healthcares & Life Sciences is focused on product development in the healthcare sector. They are seeking an R&D Design Engineer to design and develop electro-mechanical systems and components while performing system integration and utilizing PLC programming.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Under limited supervision performs mechanical, electromechanical, developmental design duties in New Product Development engineering, where some judgment is required
Experience with industrial automation, robotics, or precision instruments is a plus
Strong experience with SolidWorks / CAD software and GD&T
Must possess knowledge of good manufacturing practices and documentation, preferably in the medical industry
Knowledge of ISO 13485, Medical Device Regulatory Standards, MDD and MDR
Knowledge of statistical analysis and design of experiments (DOE) preferred. Knowledge of computer programs
Excellent interpersonal / communication skills, organizational / planning and project management skills
Personal computer skills, Microsoft Project, Windows: word processing, project planning, presentation, e-mail, web browsers & spreadsheet software
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate client policies, procedures and guidelines, the duties and responsibilities for this position are:
Identifies, designs, and develops necessary equipment related to new product development
Studies the existing processes to implement improvements on new products. Implement the automation in process and tool
Responsible for preparing and managing specifications
Assists technicians and engineers about unusual problems
Responsible for purchasing and designing equipment that meets safety and environmental requirements
Performs activities of process/product validation
Can supervise, coordinate, and technically revise the work of a limited group of technicians
Responsible for communicating business related issues or opportunities to next management level
Performs other duties assigned as needed
Qualification
Required
Design and develop electro-mechanical systems and components
Perform system integration of mechanical and electrical parts
Identifying and using stepper motors, drivers, sensors using PLC programming in Design
Strong experience with SolidWorks / CAD software and GD&T
Must possess knowledge of good manufacturing practices and documentation, preferably in the medical industry
Knowledge of ISO 13485, Medical Device Regulatory Standards, MDD and MDR
Excellent interpersonal / communication skills, organizational / planning and project management skills
Personal computer skills, Microsoft Project, Windows: word processing, project planning, presentation, e-mail, web browsers & spreadsheet software
Identifies, designs, and develops necessary equipment related to new product development
Studies the existing processes to implement improvements on new products
Implement the automation in process and tool
Responsible for preparing and managing specifications
Assists technicians and engineers about unusual problems
Responsible for purchasing and designing equipment that meets safety and environmental requirements
Performs activities of process/product validation
Can supervise, coordinate, and technically revise the work of a limited group of technicians
Responsible for communicating business related issues or opportunities to next management level
Performs other duties assigned as needed
Preferred
Knowledge and experience in product development / NPD
Knowledge of statistical analysis and design of experiments (DOE)
Experience with industrial automation, robotics, or precision instruments
Knowledge of computer programs
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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