Sr Engineer
Location: Newbury Park
Posted on: October 30, 2024
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Job Description:
Lead or support teams in the development of drug delivery
devices. Scope includes a wide range of devices, such as; needle
protection systems, fluid transfer devices, pen injectors,
automatic pen injectors, and micro-infuser delivery pump systems.
The qualified candidate will lead or support technical teams to
ensure successful device development of these mechanical and
electro-mechanical medical devices. The Senior Engineer will work
closely with team members to develop detailed engineering
specifications, device design & development, support verification,
validation, and regulatory submissions of these devices. The role
of the Senior Engineer is to work within a cross-functional
organization to utilize technologies and methodologies that support
short-cycle robust device development.
Responsibilities: - Work cross-functionally with individuals and
project teams in Marketing, Operations, and Development - Create
and assess product requirements to determine technical coverage and
proper integration different subsystems. - Create and execute to
project plans and schedules - Develop, execute, and review
architecture documents, design documents, specifications,
development plans, characterization plan, verification and
validation plans and other related product development documents
for assigned projects. - Provide deep technical assistance for
junior engineers.
Skills:
- BS in Engineering and previous experience in a medical device
industry with 2 - 10 years current experience with engineering
processes and procedures.
- Led or participated in projects from development through the 510k
and PMA approval process.
- Strong background in engineering and commercialization of
electro-mechanical and disposable medical devices.
- Experience with material & test specs generation, protocol &
report writing, process & test development, prototyping, design
verification, DOE/SPC process optimization & validation (IQ, OQ,
PQ), FMEA.
- Product design/development (design control) from concept to post
product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k)
submissions.
- Experience in drug/device combination product design and
development
- Familiar with the following standards: o Quality System
Regulation ? 21CFR820 o Risk Management ? ISO 14971 o EU Medical
Device requirements ? Council Directive 93/42/EEC o Medical
Electrical Equipment ? EN 60601 - Small scale device assembly
experience.
- Ability to read, analyze, and interpret general business
periodicals, professional journals, technical procedures, or
governmental regulations.
- Strong problem solving, risk assessment, and risk management
skills. - Must be capable of working on multiple projects in a
deadline driven environment. Plastic part design experience is a
plus. We are an equal employment opportunity employer and will
consider all qualified candidates without regard to disability or
protected veteran status.
Keywords: , Long Beach , Sr Engineer, Engineering , Newbury Park, California
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