Senior Systems Engineer Medical Device Technical Lead JP11791
Senior Systems Engineer Medical Device Technical Lead JP11791
Posted on :
07-04-2025
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1 Vacancy
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Hourly Salary
$ 46 - 51
Vacancy
1 Vacancy
Posted on :
07-04-2025
Job Description
Job Title:Senior Systems Engineer Medical Device Technical Lead (JP11791
Location:Thousand Oaks CA.
Business Unit:Final Product Technical Leads
Employment Type: Contract
Duration:18 Months with possible extensions or conversion to FTE
Rate: $46 $51/hour W2
Posting Date:09/19/2023
Notes: Qualified candidates with either a strong Electrical Engineering Mechanical Engineering OR Systems/Software Engineering background need apply and will be considered.Candidates must elaborate on their experience in Excel macros and product development on their resume.
3 Key Consulting is recruiting a Senior Systems Engineer Medical Device Technical Leadfor a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
Top Must Have Skill Sets:
Day to Day Responsibilities:
Basic Qualifications:
Preferred Qualifications:
Why is the Position Open
Planned Project.
Red Flags:
Interview Process:
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.
Business Unit:Final Product Technical Leads
Employment Type: Contract
Duration:18 Months with possible extensions or conversion to FTE
Rate: $46 $51/hour W2
Posting Date:09/19/2023
Notes: Qualified candidates with either a strong Electrical Engineering Mechanical Engineering OR Systems/Software Engineering background need apply and will be considered.Candidates must elaborate on their experience in Excel macros and product development on their resume.
3 Key Consulting is recruiting a Senior Systems Engineer Medical Device Technical Leadfor a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
- Candidates must have experience in the biotechnology pharmaceutical or medical device industry.
- Candidates must have at least 5 years experience in systems engineering.
- Candidates must have great communication skills and can lead meetings and work teams.
- Candidates must have strong background in documenting requirements and providing traceability documentation for FDA approval
- DOORS
- Requisite Pro or other similar requirements management software.
- Practical experience in configuration management and change control process/requirements CCB (change control board) CIT (change implementation team) concepts experience is preferred.
- The Systems Engineer (SE) works as part of crossfunctional program teams to deliver technical content performance intellectual property and quality deliverables of a combination product development program.
- The Systems Engineer understands and captures the user needs into system requirements and participates in the functional decomposition and allocation to subsystems.
- The Systems Engineer ensures that the quality targets are satisfied identifies technical risks and assists risk retirement activities on the program.
- The Systems Engineer maintains close interaction with customers to understand and enhance the ability to deliver on customer satisfaction through high product quality.
Top Must Have Skill Sets:
- Systems Engineering past work experience.
- Ability to communicate effectively and lead large teams in development of technical deliverables required for design control deliverables.
- Past experience in writing SOPs Guidance & technical documents is preferred but not required
- Proficient in Microsoft Excel especially in writing macros in excel.
Day to Day Responsibilities:
- 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 requirements documents design documents specifications development plans characterization plan verification and validation plans and other related product development documents for assigned projects.
- Responsible for writing technical and guidance documents that provides guidance to team members in following design control and business processes within client.
- Develop Toolsets using Microsoft excel to enable easier on boarding of other engineers onto client processes
- Work and Lead cross functional teams in development of common practices and write technical guidance documents to enable consistency across various combination product teams.
Basic Qualifications:
- BS in Engineering and previous experience in a medical device industry.
- 10 years current experience with engineering processes and procedures.
Preferred Qualifications:
- 6 years of progressive experience as an engineer or scientist within the appropriate field of study (Systems Engineering)
- Creative problem solver and solution developer when presented with conflicting requirements business demands and technical risks/issues.
- Experience in combination product development.
Why is the Position Open
Planned Project.
Red Flags:
- No degree
- No systems engineering experience
Interview Process:
- Video Conference with Hiring Manager.
- Selected candidates would then have a panel 1:1 video conference with additional team members.
- Candidate must be comfortable with video (webcam) online interview process.
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
Required Experience:
Senior IC
Employment Type
Hourly
Key Skills
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