Engineer Senior Drug Delivery Devices JP11638
Engineer Senior Drug Delivery Devices JP11638
Posted on :
06-04-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
06-04-2025
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.
Job Description:
Lead teams in the development of drug delivery devices. Scope includes a wide range of devices such as:
The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electromechanical 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 crossfunctional organization to utilize technologies and methodologies that support shortcycle robust device development. Responsibilities include:
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:
Phone Interview followed by WebEx meeting/panel interview
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone 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: $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
- Microinfuser delivery pump systems.
The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electromechanical 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 crossfunctional organization to utilize technologies and methodologies that support shortcycle robust device development. Responsibilities include:
- Work crossfunctionally 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 electromechanical 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 12 years)
- Candidates that are too green to engineering. Needs more thaneducation background.
Interview Process:
Phone Interview followed by WebEx meeting/panel interview
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Employment Type
Full Time
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