Senior Medical Devices Engineer
Company: Amerit Consulting
Location: San Diego
Posted on: August 6, 2022
Job Description:
Position: Senior Product Development EngineerLocation: San Diego
CA OR Brea CADuration: 12 Months Contract with possible extension
Pay Rate: $50/hr - $54/hr (depending on experience) Relocation
Expenses/ Assistance: NO Job Description:
- Research and Development Engineering is responsible for
development and lifecycle management of products through medical
device design control processes and good engineering and
documentation practices.
- Demonstrates working knowledge of Engineering principles and
its application in solving standard technical problems.
- Demonstrates working knowledge of product design, development,
and design control process.
- Develops technical plans for design inputs and outputs,
conducts analytical and empirical feasibility studies, develops
test methods to verify and validate subsystems and systems in order
to transfer designs alongside Manufacturing.
- Demonstrates knowledge to provide design documentation to
support global Regulatory filing strategies.
- Applies basic statistical techniques and utilizes design of
experiments with moderate guidance. Collaborates within a
cross-functional team to plan, develop, modify, implement, and
support products through the application of rigorous engineering
practices. Works with moderate guidance to achieve project
objectives.
- Flexible work arrangements allow our team members to
collaborate remotely and onsite to experiment, discover, create,
and simply connect with others toward a common purpose.
- R&D engineers are responsible for leading and supporting
projects as part of a cross-functional global team.
- This is a highly collaborative position and requires excellent
leadership, verbal, and written communication skills. Projects will
involve requirements definition, developing test methods, writing
test protocols, reports, executing verification testing, solving
test or design issues and other types of mechanical engineering
activities. Position will be required to be in the lab and office
more than 80% of the time in San Diego or Brea, CA.
- Lead R&D deliverables throughout the medical device design
control process for intravenous infusion sets and connection
devices
- Collaborate within a cross-functional team to plan, develop,
modify, implement, and support ISD products through the application
of rigorous engineering practices
- Engineer robust products through strong understanding and
application of engineering fundamentals and DFSS principles.
- Develop technical plans and guide the team to develop design
inputs, conduct analytical and empirical feasibility studies,
refine product configurations and designs, verify and validate
subsystems and systems, concurrently transfer designs alongside
Manufacturing and Operations, and provide design documentation to
support global Regulatory filing strategies
- Execute design verification testing to confirm design outputs
meet design input requirements.Required Qualifications:
- BS - Mechanical Engineering, Materials Engineering or
Biomedical Engineering
- Work experience 5 years or 3 years plus an advanced degree
- Critical thinking - able to work with moderate guidance in own
area of knowledge.
- SolidWorks or equivalent CAD tool
- Ability to manage multiple projects of varying scopes in
parallel
- Ability to work leading or as part of a cross-functional team
with members from marketing, sales, clinical, regulatory, medical
affairs, quality, manufacturing, etc.
- Experience with medical device design control processes and
creating and maintaining design control documentation.
Keywords: Amerit Consulting, San Diego , Senior Medical Devices Engineer, Engineering , San Diego, California
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