CyberCoders Senior Mechanical Engineer - Medical Products in Newport Beach, California

Senior Mechanical Engineer - Medical Products Senior Mechanical Engineer - Medical Products - Skills Required - Mechanical Engineer, 3D CAD/CAM, Manufactuiring Methods, Consumer Wearable Products, Injection Molding, Medical Devices, Monitoring Devices, FDA 510 (k) process, GMP Regulations

As the Senior Mechanical Engineer, you will be an integral part of our medical technology company that develops and manufactures innovative noninvasive patient monitoring technologies. This position works with a team of engineers on the continuous development of mobile medical devices.

The Sr. Mechanical Engineer will provide design expertise and integration in the area of Mechanical Engineering development of new products and accessories in the field of non-invasive monitoring technologies.

What You Will Be Doing

Manage the process of creating 3D models and 2D drawings for production with high standards in highly efficient time frames

Create and maintain 3D and 2D file system and process management (Solid works, Onshape or other)

Follow and achieve in making design concepts come to life in prototype, then production while conquering challenges or limitations of conventional approaches

Create and be responsible for part creation, drawings, sub-assemblies, assemblies, BOMS and packaging.

Lead vendor quoting, turn-around and specification standards

Expert with numerous manufacturing, production and assembly techniques across a wide range of materials (plastics, glass, organics, soft goods, and ceramics or others)

Document and follow a cradle to grave documentation of all parts created within ISO standards with a focus on sustainability and minimal environmental impact

Create and maintain a database on materials and their properties

Create relationships with local shops for quick turn-around validation prototypes

Manage Production schedule with WIP (raw materials, labor and overhead costs incurred at various stages)

Manage CM and supplier relationships local and overseas to drive engineering builds, reliability testing samples, track engineering change orders and design for manufacturing reviews

Take ownership of and find solutions for optimized cost reduction while still adhering to design requirement

Drive and support Verification and Validation procedures to adhere to industry standards and regulations

Work with minimal supervision and bring in or ask for support as issues arise

Work with and drive innovation from other hardware teams to insure any difficulties are solved internally before production or issues ever reach the user

Directs and facilitates the testing of new products to verify product reliability. Leads the development of technical protocols and reports.

Advanced understanding of statistical analysis principles as they relate to data analysis and testing reports.

Additional opportunities and responsibilities as required

What You Need for this Position

MS or BS Degree Mechanical Engineering or in a related discipline

6+ years experience in mechanical engineering for consumer products or medical devices

Experience in the medical device industry

Highly proficient in 3D software packages

Proven success working on commercially available consumer or medical devices

Previous experience with numerous materials and manufacturing methods

Portfolio and/or URL samples of drawings, cad work and material selection

Ability to cleanly organize and document design process and highly organized with file management

Understanding of best practices and supporting audits internal and external

Ability to work independently, while escalating issues as necessary

Prior Medical device manufacturing experience, with working knowledge of:

FDA 510(k) approval process

ISO standards

GMP regulations

Excellent conceptual, analytical, and problem-solving ability.

Experience working in both large structured and small entrepreneurial organizations.

Excellent communication, collaboration, presentation, and interpersonal skills

For your hard work and dedication, earn a generous salary, possible bonus, plus comprehensive benefit package. Enjoy the opportunity to join a collaborative company offer a career path.

Applicants must be authorized to work in the U.S.

CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Senior Mechanical Engineer - Medical Products CA-Newport Beach NG-1455633