Senior Systems Engineer, Medical Device Technical Lead - Remote (Jp11883)

Job Title: Senior Systems Engineer, Medical Device Technical Lead – Remote (JP11883)
Location: Thousand Oaks, CA. (Remote, preferably local)
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.  May consider remote if candidate can adhere to Pacific coast time zone.  Preferred local candidates.  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 Lead for 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 cross-functional 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 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 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.
• 6 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 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.