Mid-Sr Mechanical Eng (FDA/Disposables)

    • Carlsbad, CA

RESPONSIBILITIES:
Kforce has a client that is seeking a Mid-Sr Mechanical Eng (FDA/Disposables) in Carlsbad, CA. This role is currently 100% remote and will switch back to an office environment when COVID-19 restrictions are lifted. Summary: The Mid-Sr Mechanical Eng (FDA/Disposables) designs, prototypes, and analyzes medical devices, equipment and associated processes and packaging. The Mid-Sr Mechanical Eng (FDA/Disposables) conducts feasibility studies and testing on new and modified designs. Directs support personnel in the preparation of detailed design, design testing and prototype fabrication. Documents design and process information in quality system records. Duties and Responsibilities

  • Works on engineering tasks related to the design and manufacturing of disposable and electromechanical medical devices
  • May research and develop new components, assemblies, and processes as needed
  • Participates in review of research and product development activities; assists in the build and test of engineering prototypes and processes
  • Generates test protocols, performs tests, and generates reports for product and process design verification testing
  • Performs product packaging design tasks including the definition of constraints.
  • Responsible for some aspects of the product lifecycle as a Mechanical Engineer which may include documentation and initiating drawings, documents and specifications for piece parts, assemblies and processes
  • Is a collaborative team player and demonstrates open-mindedness and flexibility
  • Creates innovative and creative solutions to keep projects on-track. Maintains a high degree of quality in all work performed
  • Responsible for compliance with quality system procedures and all regulatory requirements
  • Consistently promote collaboration, positivity, accountability and resourcefulness
  • Must demonstrate mutual respect, ongoing communication and a positive outlook with both internal team members and customers


REQUIREMENTS:
  • Typically requires a minimum of 3 years of related experience and a Bachelor's degree in a scientific/engineering discipline, or 2 years of experience and a Master's degree; or equivalent combination of education and experience
  • Working experience with Solidworks and Prochain is highly desired
  • Experience with medical device assembly, processing and rapid prototyping
  • Working knowledge of Design Controls, Verification, Validation and Design Transfer
  • Demonstrates technical proficiency. Regularly collaborates with others in suggesting valuable solutions as an active contributor.
  • Must be able to understand job duties and responsibilities, have the necessary skills/knowledge and be willing and able to continue learning and growing within the field
  • Must be skilled at managing a significant workload and obtaining positive results, taking on additional responsibility and managing priorities as needed
  • Must be accurate, detailed, committed to high quality standards and pro-active in finding solutions to achieve successful outcomes
  • Strong verbal and written communication skills with the ability to produce accurate, punctual reports/information, as required and thoroughly share information with others; Must be able to read, write and speak effectively
Qualified candidates must be presently authorized to work in the United States on a full-time basis. This company does not sponsor or transfer H1-visa individuals. Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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