Job Summary
This is a hands-on individual contributor position with responsibility for the following areas: support 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: $99,000 - $148,000
Job Details/Responsibilities
1. Concept Development: Able to provide input to the development of unique solutions to complex problems that solve clinical challenges, as well as engineering challenges as they relate to product and manufacturing.
2. Design Development: Able to provide to 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.
3. Component and Materials Sourcing: Able to 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.
4. Verification and Validation Efforts: Able to drive efforts that test the frozen design against the market and technical requirements of the finished good,
a. Can establish, and release protocols to test the design against the customer requires specification or the product specification
b. Drive the build(s) of traceable lots of finished goods that can be tested under the released protocols.
c. Coordinate and/or lead 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.
d. Ensures effective data collection, data analysis, document drafting, and report releasing based on the requirements established in the protocol.
Job Responsibilities (continued)
5. 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. 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.
6. Manufacturing Engineering: Support Manufacturing Engineering group in process validation activities. Design and qualify tooling and equipment for the timely and cost-effective manufacture of products. Work directly with Production and Quality Assurance Personnel to ensure that manufacturing documentation is in accordance with the Quality Systems.
7. Supervision: May be required to train Assemblers and Technicians in the project group.
8. Regulatory Compliance: Provide support in engineering testing and documentation that is in accordance with regulatory requirements for approvals of products by the U.S. and foreign regulatory agencies.
9. Responsibilities to the Quality System: Support the Quality System and Quality Policy. Be aware of Quality System procedures and requirements including regulatory requirements and training requirements for position activities. Inform responsible personnel of concerns involving product quality.
10. Intellectual Property: Ensures technical activities are properly documented in lab notebook. Participates in and contributes to technical discussion sessions to generate new intellectual property.
11. 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.
12. Other Duties: As assigned.
Working Conditions/Physical Requirements
This position is located in Campbell, California and requires 10-20% travel to Terumo facilities and other destinations such as hospitals or suppliers.
Knowledge, Skills and Abilities (KSA)
1. Demonstrated skill in analytical problem solving; ability to systematically investigate issues and implement fixes under general supervision.
2. Demonstrated skill in technical writing; ability to write low level documents such as Manufacturing Process Instructions and Component Specifications under general supervision. Ability to generate higher level documents such as Protocols and Reports under regular supervision.
3. Basic understanding 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 MDD 93/42/EE.
4. Ability to execute established procedures and protocols under general supervision.
5. Ability to train Assemblers and Technicians to applicable standards.
6. Ability to manage small projects under regular supervision.
7. Proficiency using general business software like Microsoft Office and Windows applications; Word, Excel, PowerPoint, Project.
8. Skilled in the use of CAD software such as AutoCAD, SolidWorks, Pro Engineer (preferred).
9. Skilled in the use of statistical analysis software such as Excel or Minitab.
10. Knowledge of data collection, analysis, and documentation techniques.
11. Knowledge of Design Control procedures and requirements, including risk management.
Qualifications/ Background Experiences
- Bachelors degree in sciences, Engineering or related discipline required, Masters degree preferred, or equivalent combination of education, training and experience.
- Minimum of 2 years previous experience in design, manufacturing or quality engineering required.
- Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD required.
- Experience in a start-up environment preferred.
- Experience with catheter-based medical devices preferred.
