R&d Engineer I Job In San Clemente, California, Katalyst Healthcares & Life Sciences

Published 2022-08-10
Expires 2022-09-10
ID #1121186589
R&d Engineer I Job In San Clemente, California, Katalyst Healthcares & Life Sciences
United States, California, San Clemente,
Published August 10, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Per annum
Occupation: R&d engineer i

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The R&D Engineer will support the Business Development R&D department. The R&D Engineer is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices. The key responsibility of this position is to design, develop, and improve CLIENT's product portfolio to ensure their efficiency and reliability. The incumbent will be heavily involved with plastics, polymers, molding, medical disposables, plastics engineering, and solid modeling. The R&D Engineer will be expected to interface mainly with internal customers and external suppliers on the design and configuration of high-volume disposable medical devices. The position plays a key role in assisting in the development and compliance challenges involved with new medical devices. The position requires the ability to interact with multiple functional groups such as Marketing, Regulatory, Quality, Operations, etc.


Roles & Responsibilities:

Assist in the development of products from concept to production

Develop product requirements according to customer and business needs in compliance with international standards and regulations applicable.

Adhere to established design control processes and good engineering practices

Design and model components and devices for various product lines using SolidWorks

Evaluate parts, products, or processes for efficiency and reliability to ensure long-term success of new / improved product lines

Provides technical support on components, material methods, systems and equipment

Provides the technical foundation for the development of risk documentation

Develops test procedures to ensure specifications and regulations are met

Writes, reviews, and approves protocols, reports and data

Conducts testing outlined in protocols and test methods

Executes engineering and validation studies on products

Conducts failure investigations

Work on special assignments as they arise

Education & Experience:

Bachelor of Science degree from an accredited college or university in Mechanical Engineering or a related field. Master's Degree preferred.

0-2 years of experience in Medical Device Product Development and/or Manufacturing Support Engineering

Detail oriented and ability to organize large amounts of work and data.

Strong interpersonal skills required in the areas of verbal and written communications, customer focus,   

time management, professionalism, coaching, influencing, and team building.

Knowledge of medical device manufacturing practices

Knowledge of medical grade plastics and general injection molding principles

Strong knowledge in joining methods of plastics

Experience with design of experiments (DOE) and basic statistical methods

Excellent project leadership and ability to expedite project completion

SolidWorks competency required

Understanding of engineering mechanics and physics

Familiarity with machine shop practices

Familiarity of drafting standards

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    Employer's info

    Katalyst Healthcares & Life Sciences
    Registered on October 7, 2017


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    Manufacturing is the production of merchandise for use or sale using labour and machines, tools, chemical and biological processing, or formulation. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale. Such finished goods may be sold to other manufacturers for the production of other, more complex products, such as aircraft, household appliances, furniture, sports equipment or automobiles, or sold to wholesalers, who in turn sell them to retailers, who then sell them to end users and consumers.

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