Senior Engineer - Aditi Consulting
Thousand Oaks, CA
About the Job
Pay Rate: $40 - $44/hr.
Summary:
Sr level role. Must have experience in the Biotech, pharma, med device industry. must have systems engineering background for at least 5 years candidate. Great communication can lead meetings and work screens. Must have: Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, 3DS (Dassault), Requisite Pro, or other similar requirements management software. Nice to have: Practical experience in configuration management and change control process/requirements, CCB (change control board), CIT (change implementation team) concepts.
Responsibilities:
Skills:
Preferred Qualifications:
Top 3 Must Have Skill Sets:
Day to Day Responsibilities:
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
#AditiConsulting
Summary:
Sr level role. Must have experience in the Biotech, pharma, med device industry. must have systems engineering background for at least 5 years candidate. Great communication can lead meetings and work screens. Must have: Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, 3DS (Dassault), Requisite Pro, or other similar requirements management software. Nice to have: Practical experience in configuration management and change control process/requirements, CCB (change control board), CIT (change implementation team) concepts.
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 of 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.
Skills:
- 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.
Top 3 Must Have Skill Sets:
- Systems Engineering past work experience
- Experience in writing Requirements using Requirements Management Tool such as DOORS, 3DS Requirements Mgmt (Dassault) etc
- Proficient in Microsoft Excel especially in writing macros in excel and or Smartsheet.
Day to Day Responsibilities:
- Responsible for writing technical and guidance documents that provides guidance to team members in following Requirements Management Toolset such as 3DS.
- Develop Toolsets using Microsoft excel or SmartSheet to enable easier on boarding of other engineers onto 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.
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
#AditiConsulting
Source : Aditi Consulting