Job Title:  Engineer Senior, Drug Delivery Devices (JP11638)
Location: Louisville, KY. 40201
Business Unit: Logistics and Transportation.
Employment Type:  Contract
Duration: 1+ years (with possible extensions)
Rate: $46 - $51hour W2
Posting Date: 06/01/2023
Notes: Only Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered. 

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.

The qualified candidate will lead 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 include:
 

• 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.

Top Must Have Skill Sets:

• 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!!!

Day to Day Responsibilities:

• Third Party Supplier management
• Inventory analysis and management
• Analytical reporting and data collection

Basic Qualifications:

• 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.

Why is the Position Open?
Supplement additional workload on team

Red Flags:

• Excessive changes in employers over short span (1-2 years)
• Candidates that are too green to engineering. Needs more than education background.

Interview Process:
Phone Interview followed by WebEx meeting/panel interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.