Apply to Engineer Senior, Combination Medical Devices (JP11927)

Job Title: Engineer Senior, Combination Medical Devices (JP11927)
Location: Louisville, KY. 40201
Business Unit: Logistics and Transportation
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate: $44 - $46/hour W2
Posting Date: 10/26/2023
Notes: VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!! Onsite preferred. (Hybrid - in the office monthly to bimonthly). Remote - MUST adhere to Eastern time zone. *** Please provide sample writing if available

3 Key Consulting is recruiting an Engineer Senior, Combination Medical Devices for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
The Ideal Candidate:

Individual must have background with data analysis.
Ability to receive, validate and manipulate those reports.
Excellent technical writing skills.
Prefers a Masters in Engineering and 3 YOE.
Must have experience in a GMP environment.
Needs to have Biotech/Pharma/ Med Device exp.

Summary of Role:

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, and 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.

Top Must Have Skill Sets:

Technical writing skills-experience in writing on owning GMP documents and records.
Oversight and management of multiple projects and tasks for 3rd party suppliers.
Data analysis to develop insights and strategies.

Day to Day Responsibilities:

Management of 3rd party supplier ensuring Quality Agreement is adhered to Quality record ownership.
Tracking of key metrics and performance indicators.
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 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.

Basic Qualifications:

Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR
Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.
BS in Engineering and previous experience in a medical device 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:
- 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 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:

Extensive job history within short period of time
No experience in GMP working environment

Interview Process:
1:1 Phone, then 1:2 Webex interview. Available to begin interviews 10/27/23

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.