Engineer Senior Drug Delivery Medical Device JP9905
Engineer Senior Drug Delivery Medical Device JP9905
Posted on :
11-04-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
11-04-2025
Job Description
Job Title:Engineer Senior Drug Delivery Medical Device (JP9905
Location:Thousand Oaks CA.
Employment Type: Contract
Business Unit:Mechanical Autoinjectors Platform
Duration:1 years (with likely extensions and/or conversion to permanent)
Posting Date:3/2/2022
3 Key Consulting is hiring anEngineer Seniorfor a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
Support the 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 microinfuser delivery pump systems. The qualified candidate will support technical teams to ensure successful device development of these mechanical and electromechanical medical devices. The Sr. Engineer will work closely with device Subject Matter Expert (SME) to support develop detailed engineering specifications device design & development support verification validation and regulatory submissions of these devices. The role of the Sr. Engineer is to work within a crossfunctional organization to utilize technologies and methodologies that support shortcycle robust device development.
Responsibilities include:
Why is the Position Open
Supplement additional workload on team
Top Must Have Skills:
Day to Day Responsibilities:
Support and manage day to day commercial advancement operation to ensure deliverables and deadlines are met. Coordinate activities and provide guidance to jr. engineers
Basic Qualifications:
Employee Value Proposition:
Great biotech/pharma to work for.
Red Flags:
Applicants without 5 years of experience with one company.
Interview process:
Video Skype Panel Interview
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at the other positions on our websitehttps:// You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
Location:Thousand Oaks CA.
Employment Type: Contract
Business Unit:Mechanical Autoinjectors Platform
Duration:1 years (with likely extensions and/or conversion to permanent)
Posting Date:3/2/2022
3 Key Consulting is hiring anEngineer Seniorfor a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
Support the 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 microinfuser delivery pump systems. The qualified candidate will support technical teams to ensure successful device development of these mechanical and electromechanical medical devices. The Sr. Engineer will work closely with device Subject Matter Expert (SME) to support develop detailed engineering specifications device design & development support verification validation and regulatory submissions of these devices. The role of the Sr. 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 Quality Operations and Development.
- Create and assess product requirements to determine technical coverage and proper integration different subsystems.
- Execute to project plans and schedules.
- Develop execute and review architecture documents design documents specifications development plans characterization plans verification and validation plans and other related product development documents for assigned projects.
- Provide technical assistance for junior engineers.
Why is the Position Open
Supplement additional workload on team
Top Must Have Skills:
- 5 years min experience in device engineering end to end configuration control management
- Design characterization verification .
- Device design experience (design for six sigma experience a
Day to Day Responsibilities:
Support and manage day to day commercial advancement operation to ensure deliverables and deadlines are met. Coordinate activities and provide guidance to jr. engineers
Basic Qualifications:
- BS in Engineering and previous experience in a medical device industry.
- 10 years current experience with engineering processes and procedures.
- 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).
- 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 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.
- VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering Mechanical Engineering OR Systems Engineering background need apply and will be considered!!!
Employee Value Proposition:
Great biotech/pharma to work for.
Red Flags:
Applicants without 5 years of experience with one company.
Interview process:
Video Skype Panel Interview
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at the other positions on our websitehttps:// You are welcome to also 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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