Job Description

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.

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.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry

Unknown

Company Size

1-10 employees

Headquarters

Simi Valley, CA

Year Founded

2009

Website

3keyconsulting.com

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