Company: Diverse Lynx
Posted on: November 26, 2022
Bachelors degree in engineering or science (Biomedical, Mechanical,
Electrical, Biology, etc)
3+ years of medical device industry experience in design control
and/or project engineering
- Ability to quickly build connections with internal and external
- Ability to manage multiple projects and tasks
- Ability to read engineering drawings, GD&T, terminology,
- Knowledge and experience in product development processes and
design control is preferred.
- In-depth knowledge of design of medical devices
- Ability to be a technical leader on multi-functional
- Excellent verbal and written communication skills, including
but not limited to, the ability to relate technical requirements,
listen effectively, influence decision-makers by data and be able
to receive constructive input from others.
- Ability to solve complex problems
Roles & Responsibilities
Under limited supervision and in accordance with all applicable
federal, state and local laws/regulations and Corporate, procedures
and guidelines, the duties and responsibilities for this position
- Responsible for the successful planning, coordination,
execution, implementation, and timely completion of project
deliverables ensuring consistency with company policies,
procedures, and commitments
- Lead and drive execution of design for manufacturing including
component manufacturing within the principles of DMAIC
- Ensure on-schedule and on-cost delivery of projects while
managing project activities during all phases such as Engineering,
Documentation, Process, Operations, Planning, etc.
- Communicate with all project stakeholders, core team, extended
team, and cross-functional members
- Develop innovative workflows to generate compelling technical
evidence of product or project performance under challenging
- Prepare and present technical information in a clear and
effective manner to project leads, managers, stakeholders
- Review and coordinate drawings, BOMs, specifications,
protocols, test reports, plans, etc.
- Actively coordinate and mitigate delays within project and
- Collaborate with cross-functional team, work with engineering,
manufacturing, marketing and suppliers
- Ensure continued compliance of project and/or portfolio to
applicable standards and regulations
- Create, track, and maintain all project documentation and
progress such as Design History File, Design History Records,
Engineering Change Orders, Technical File, etc.
- Follow strict adherence to policies and procedures associated
with FDA and any other Notified Body (EU-MDR, PMDA, NMPA, ANVISA,
etc) controlled environment
Generic Managerial Skills
Project Management experience
A minimum of bachelors degree in Electrical, Mechanical or
Biomedical Engineering or masters degree in Electrical, Mechanical
or Biomedical Engineering.
Diverse Lynx LLC is an Equal Employment Opportunity employer. All
qualified applicants will receive due consideration for employment
without any discrimination. All applicants will be evaluated solely
on the basis of their ability, competence and their proven
capability to perform the functions outlined in the corresponding
role. We promote and support a diverse workforce across all levels
in the company.
Keywords: Diverse Lynx, Irvine , Project Engineer, Engineering , Irvine, California
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