Demo

System Engineer

BioTalent
Orange, CA Full Time
POSTED ON 2/26/2025
AVAILABLE BEFORE 5/23/2025

The Systems Engineer will be an integral member of our client's engineering team, responsible for verification and validation of all engineering aspects of their implantable product. With superior technical ability, the Systems Engineer is required to develop system specifications, develop test methods, and perform or supervise component, integration, and system tests of the device.

This position will undertake and document experiments to verify the device design in order to reliably and repeatedly produce a device that meets the design input specification. Working closely with management and internal company engineers will assure the long-term value and viability of products.

Our client is looking for motivated team members who are keen to contribute to this active and dynamic project. This role requires creativity and flexibility to find the best solution in a multidisciplinary and dynamic R&D environment. Strong leadership in a team environment, organizational, time / project management, and technical skills are required.

RESPONSIBILITIES

  • Specification of component and system test requirements.
  • Analyze product specifications in cooperation with teams from electrical, mechanical, and software engineering.
  • Develop system test specifications, feasibility plans, and sets of verification and validation tests that meet design input specifications.
  • Designing and development of efficient test facilities according to defined specifications.
  • Take technical leadership in the development of validation and verification test facilities.
  • Design test strategies, test procedures, and test cases to verify the behavior of components and systems as compared to the specified requirements.
  • Apply interdisciplinary technical standards, principles, theories, concepts, and techniques.
  • Equipment identification, design, installation, and validation.
  • Conduct and report on experiments for verification and validation of the product input specifications.
  • Plan, schedule, conduct, and coordinate detailed phases of work relating to validation and verification.
  • Create work instruction documentation that describes the testing procedures.
  • Verify test completeness and consistency of devised testing procedures.
  • Technically supervise or liaise with / coordinate the work of technicians.
  • Feedback into the development, manufacturing, and support divisions of our client’s TAH.
  • Develop system models and simulation artifacts to understand system behavior, system performance, or technical attributes.
  • Participate in failure analysis / corrective action activities to determine and direct design modifications.
  • Assist in risk analysis and fault analysis studies and support regulatory submissions of specifications, test plans, and reports.

REQUIREMENTS

  • Bachelor’s degree in electrical, Biomedical Engineering, or equivalent.
  • Postgraduate qualification desired (Master of Science, Master of Engineering, PhD).
  • Working knowledge of process characterization, pFMEAs, MVP, IQ / OQ / PQ / PPQ, and TMVs is desirable.
  • An understanding of medical device quality regulations, practices, and quality standards, such as ISO 13485, ISO 9001, ISO 14708, IEC 60601-1, and FDA Quality System Regulations.
  • Experienced in component, integration, and system tests.
  • Minimum 1 year in the medical device development field.
  • Project and team management preferred.
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