R&D Engineer I

3 weeks ago

San Jose, United States Actalent Full time

Job Title: R&D Engineer I

Job Description

This position is responsible for aspects of the product design and development of a project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. The engineering manager plans, organizes and directs engineering staff to meet company objectives for design, new product development and improvement of existing product lines by performing the following duties personally or through subordinates. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

Essential Functions

  • Support R&D team to design and test catheters and delivery systems

  • Develop concepts, designs and details for machines, tools and

  • Support includes overall design, design for manufacturing, test method development, and product verification and validation testing

  • Participate in technical discussions and decision making with cross functional

  • Interface between external vendors and core teams

  • Develop specifications, engineering blueprints and detail

  • Resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.

  • Provide design changes for existing Ensures proper documentation of changes.

  • Create engineering designs, develop plans and keep laboratory notebooks on all

  • Assist with testing (Bench, V&V, in vivo); develop and utilize test protocols; generate written reports.

  • Travel to customer sites, domestic and international, to gather VOC, perform testing and/or perform troubleshooting activities.

  • Responsible for supporting design reviews and pre-validation assessments to ensure the safe and environmentally sound processes and designs.

  • Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.

  • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.

  • Responsible for communicating business related issues or opportunities to next management level.

  • Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.

  • Performs other duties assigned

Qualifications

  • Bachelor's Degree in Mechanical or Biomedical Engineering

  • Master's Degree in Mechanical or Biomedical Engineering

  • Must have three (3) plus years' relevant Engineering experience

  • Knowledge and experience in catheter design

  • Experience with CAD software such as AutoCad or Solidworks

  • Knowledge and experience in development processes and in documentation writing

  • Experience with statistical analysis and design of experiments (DOE)

  • Ability to use PC and associated software

  • In-depth knowledge of material and metals

  • Knowledge of Good Manufacturing Process and Good Documentation

Job Type

This is a permanent position.

Work Site

This is a fully on-site position in Fremont, California.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent

  • Maintaining an inclusive environment through persistent self-reflection

  • Building a culture of care, engagement, and recognition with clear outcomes

  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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