Engineer Senior, Drug Delivery Medical Device (JP9905)
Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Engineer Senior, Drug Delivery Medical Device (JP9905) Location: Thousand Oaks, CA. Employment Type: Contract Business Unit: Mechanical Autoinjectors Platform Duration: 1+ years (with likely extensions and/or conversion to permanent) Posting Date: 3/2/2022
3 Key Consulting is hiring an Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description: Support the 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 support technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Sr. Engineer will work closely with device Subject Matter Expert (SME) to support develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Sr. Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
Work cross-functionally with individuals and project teams in Quality, Operations, and Development.
Create and assess product requirements to determine technical coverage and proper integration different subsystems.
Execute to project plans and schedules.
Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plans, verification and validation plans and other related product development documents for assigned projects.
Provide technical assistance for junior engineers.
Why is the Position Open? Supplement additional workload on team
Top Must Have Skills:
5 years min experience in device engineering end to end configuration control management
Design characterization, verification execution.
Device design experience (design for six sigma experience a +)
Day to Day Responsibilities: Support and manage day to day commercial advancement operation to ensure deliverables and deadlines are met. Coordinate activities and provide guidance to jr. engineers
BS in Engineering and previous experience in a medical device industry.
10 years current experience with engineering processes and procedures.
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).
Experience in drug/device combination product design and development.
Familiar with the following standards:
Quality System Regulation 21CFR820 - Risk Management; ISO 14971 - EU Medical Device requirements; Council Directive 93/42/EEC - Medical Electrical Equipment; EN 60601 - Small scale device assembly experience.
Ability to read, analyze, and interpret general 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.
VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems Engineering background need apply and will be considered!!!
Employee Value Proposition: Great biotech/pharma to work for.
Red Flags: Applicants without 5 years of experience with one company.
Interview process: Video Skype Panel Interview
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website https://3kc.catsone.com/careers/2010-General. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.