Job Information
Terumo Medical Corporation Sr R&D Engineer II in Campbell, California
Sr R&D Engineer II
Date: Jan 27, 2025
Req ID: 4218
Location:
Campbell, CA, US
Company: Kalila Medical Inc.
Department: Atherectomy & Thrombectomy
Job Summary:
The Sr. R&D Engineer II is a hands-on individual contributor position with some portion of leadership/management elements, and responsibility for the following areas: concept/design development, component/material sourcing, design verification and validation, project engineering, and early manufacturing engineering, in accordance with the company’s Quality System and customer requirements.. Salary range: $134,100 - $201,100
Job Details:
Concept Development: Drive the development of unique solutions to complex problems that solve clinical challenges, as well as engineering challenges as they relate to product and manufacturing.
Design Development: Can take a concept to reality, converting prototype materials into manufacturable components and assemblies. This includes decisions on whether to insource or outsource certain assembly processes, based on capability, and cost. This includes the ability to determine best options for manufacturing, whether injection molded, machined, or otherwise, knowing what will help to make a component or material that meets the functional needs at a reasonable price.
Component and Materials Sourcing: Can identify suppliers for individual components and materials, and support specification development, procurement, component inspection, and resolution of non-conformances related to receipt of first lots.
Verification and Validation Efforts: Can drive efforts that test the frozen design against the market and technical requirements of the finished good,
Protocols, can establish, and release protocols to test the design against the customer requires specification or the product specification, and establishes high level plans for overall execution and management
Builds, drive the build(s) of traceable lots of finished goods that can be tested under the released protocols.
Testing, drive testing the finished goods per the released test methods, as defined in the released protocols. Tests to include simple visual inspections and dimensional measurements using equipment such as Instrons, leak testers, and other complex pieces of equipment.
Reports, drive data collection, data analysis, document drafting, and report releasing based on the requirements established in the protocol.
Project Engineering: As part of a project team, or on an individual basis contribute to the development of detailed specification, construction of prototypes for new products or current product enhancements. May be required to manage individual projects. Design product testing protocols. Set up and run product testing and protocols in accordance with project plans. Research and recommend vendor and material choices for product. Required to prepare and deliver status reports. Ensure that product documentation is in accordance with Quality System requirements.
Project Management: Provide input and may coordinate multi-functional project team activities from early project conceptualization through clinical testing when required. Create, maintain, and manage overall project schedule, and ensure that critical timelines and/or budgets are established and met. Conduct regular project team meetings to ensure communication between multi-functional team members. Develop positive proactive working relationships with team members and other staff.
Manufacturing Engineering: Work with the manufacturing engineering group to develop manufacturing engineering and process specifications for products scheduled for release to Manufacturing and support all process validation activities. Determine tooling and equipment needs for the timely and cost-effective manufacture of products. Work with R&D staff to ensure smooth transition and manufacturability of products in conformance with regulatory and Company requirements. Work directly with R&D, Production and Quality Assurance Personnel to ensure the manufacturability of products in accordance with the Quality Systems, operator ability, and cost requirements.
Product Enhancements: Design prototypes and product modifications in response to pre-clinical trials and customer feedback. Research, design and develop new products and current product enhancements in accordance with Quality System requirements.
Facilities/Equipment Planning/Engineering: Manage manufacturing equipment design, development and qualification to ensure that equipment is cost effective and meets manufacturing specifications. Work with Equipment coordinator for all calibration and preventive maintenance activities in accordance with the Company's Quality System requirements.
Supervision: May be required to supervise, lead or train Engineers, Assemblers and Technicians in the project group.
Regulatory Compliance: Provide engineering testing and manufacturing documentation that is in accordance with regulatory requirements for approvals of products by the U.S. and foreign regulatory agencies.
Responsibilities to the Quality System: Support the Quality System and Quality Policy. Be aware of and contribute to improvement changes in Quality System standard operating procedures (SOPs) and requirements including regulatory requirements and training requirements for position activities. Ensure subordinate staff are trained in applicable procedures prior to performing Quality related activities. Inform responsible personnel of concerns involving product quality.
Intellectual Property: Ensures technical activities are properly documented in lab notebook. Participates in and contributes to technical discussion sessions to generate new intellectual property.
Safety: Perform all activities and documentation related to employee health and safety and ensure compliance with all legal and regulatory requirements. Performs job functions in a safe and effective manner. Ensures that employees under position supervision are adhering to the safety procedures of the company.
Other Duties: As assigned.
Knowledge, Skills and Abilities (KSAs)
Demonstrated skill in analytical problem solving; ability to systematically investigate issues and implement fixes under general supervision.
Demonstrated skill in technical writing; Ability to generate higher level documents such as Protocols and Reports, Risk documentation, Quality plans.
Working knowledge of key regulations/standards for medical product manufacturing and development: 21 CFR 820 (Quality System Regulation), 21 CFR 803 and 804 (MDR regulations), ISO 13485, ISO 14971, and EU/MDR 2017/745 is preferred.
Ability to execute established procedures and protocols under general supervision.
Ability to train Assemblers and Technicians to applicable standards.
Ability to manage small projects.
Proficiency using general business software like Microsoft Office and Windows® applications; Word, Excel, PowerPoint, Project.
Knowledge of data collection, analysis, and documentation techniques.
Knowledge of Design Control procedures and requirements, including risk management.
Skilled in the use of CAD software such as Auto cad, Solid works, Pro E.
Skilled in the use of statistical analysis software such as Excel or Minitab.
Position Requirements - Required Background Experiences
Bachelor’s degree in Engineering or related discipline, Master’s degree preferred, and a minimum of 12 years previous experience required; or equivalent combination of education, training and experience.
3+ years of experience in the medical device industry preferred.
Design verification and validation experience required.
Test method validation experience required.
Process validation experience; experience in validating product manufacturing processes to FDA compliance required.
Experience with Design Control procedures and requirements, including risk management required. ISO 14971
Experience with catheter manufacturing and assembly methods preferred.
Terumo Medical Corporation
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