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Engineer Senior, Combination Medical Devices (JP11927)
Louisville, KY · Biotech/PharmaceuticalJob 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:
Summary of Role:
Top Must Have Skill Sets:
Day to Day Responsibilities:
Basic Qualifications:
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
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.
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.
Regards,
3KC Talent Acquisition Team