Engineer Senior Drug Delivery Medical Device JP9612
Engineer Senior Drug Delivery Medical Device JP9612
Posted on :
15-03-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
15-03-2025
Job Description
Job Title: Engineer Senior Drug Delivery Medical Device (JP9612
Location: Thousand Oaks CA.
Employment Type: Contract
Business Unit: FPT Development Product Engineering
Duration: 1 years (with likely extensions and/or conversion to permanent)
Posting Date: 1/3/2022
3 Key Consulting is hiring a Senior Engineerfor a consulting engagement with our direct client a leading global biopharmaceutical 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 and 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:
Why is the Position Open
Planned project.
Top Must Have Skills:
Day to Day Responsibilities:
Basic Qualifications:
Red Flags:
Interview process:
Video Skype 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: Thousand Oaks CA.
Employment Type: Contract
Business Unit: FPT Development Product Engineering
Duration: 1 years (with likely extensions and/or conversion to permanent)
Posting Date: 1/3/2022
3 Key Consulting is hiring a Senior Engineerfor a consulting engagement with our direct client a leading global biopharmaceutical 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 and 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.
Why is the Position Open
Planned project.
Top Must Have Skills:
- Design controls.
- Mechanical testing.
- Drug delivery experience.
- Risk base process.
- Presentation skills.
Day to Day Responsibilities:
- Author device documentation to support development planning verification validation and transfer.
- Author test protocols and execute mechanical testing of drug delivery devices.
- Presentation and communication skills (within program teams).
- Execute and deliver within regulated development processes.
- Proactively maintains close communication with technical leads.
Basic Qualifications:
- 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 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:
- 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.
- MERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering Mechanical Engineering OR Systems/Software Engineering background need apply and will be considered!!!
Red Flags:
- Less than 5 years of experience.
- Jumpy job history.
- Lack of enthusiasm and not selfmotivated.
Interview process:
Video Skype 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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