12 Engineer Senior, Drug Delivery Devices (JP11638) - REMOTE Jobs in Thousand Oaks, CA
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Engineer Senior, Drug Delivery Devices (JP11638) - REMOTE
$98k-119k (estimate)
Full Time | Business Services
6 Months Ago
3 Key Consulting is Hiring a Remote Engineer Senior, Drug Delivery Devices (JP11638) - REMOTE
Job Title: Engineer Senior, Drug Delivery Devices (JP11638) - REMOTELocation: Louisville, KY. 40201 - REMOTEBusiness Unit: Logistics and Transportation.Employment Type: ContractDuration: 1 years (with possible extensions)Rate: $46 - $51hour W2Posting Date: 06/01/2023Notes: OnlyQualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered. Remote role. possible need for in sporadic onsite meetings manager prefers local to Louisville or east coast time zone.
3 Key Consulting is recruiting an Engineer Senior, Drug Delivery Devices for a consulting engagement with our direct client, a leading global biotechnology company.Job Description:Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as:
3 Key Consulting is recruiting an Engineer Senior, Drug Delivery Devices for a consulting engagement with our direct client, a leading global biotechnology company.Job Description:Lead 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
- Micro-infuser delivery pump systems.
- 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.
- Systems/Software Engineering background
- Strong problem solving, risk assessment, and risk management skills.
- Create and execute to project plans and schedules
- Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!
- Third Party Supplier management
- Inventory analysis and management
- Analytical reporting and data collection
- BS in Engineering and previous experience in a medical device industry, supply chain and QA in a medical industry.
- 10 years current experience with engineering processes and procedures.
- Led projects from development through the 510k and PMA approval process.
- Strong background in engineering and commercialization of electro-mechanical 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.
- Excessive changes in employers over short span (1-2 years)
- Candidates that are too green to engineering. Needs more than education background.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$98k-119k (estimate)
POST DATE
12/13/2023
EXPIRATION DATE
06/30/2024
WEBSITE
3keyconsulting.com
HEADQUARTERS
WEST HILLS, CA
SIZE
100 - 200
FOUNDED
2009
TYPE
Private
REVENUE
$50M - $200M
INDUSTRY
Business Services
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