Engineer Senior, Drug Delivery Medical Device JP

Position: Engineer Senior, Drug Delivery Medical Device - (JP9675)
Job Title: Engineer Senior, Drug Delivery Medical Device - (JP9675)
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: 1/13/2022
Notes:

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.

Responsibilities include:

• 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 plan, 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:


1. 5 years min experience in device engineering end to end configuration control management
2. Design characterization, verification execution.
3. 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

Basic Qualifications:

• 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 21
    
    CFR
    820 - 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 sendyour resume  Ifyou decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our  You are also welcome to sharethis opportunity with anyone you think might be interested in applying for this role.
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