Job Title: Systems Engineer
Location: Remote (Pacific Time Zone adherence required)
Job Summary:
- We are seeking a seasoned Systems Engineer with a strong background in the Biotech, Pharma, or Medical Device industry. The ideal candidate will have a solid foundation in systems engineering, excellent communication skills, and the ability to lead meetings and work screens. This role involves working as part of cross-functional teams to deliver high-quality combination product development programs.
Key Responsibilities:
- Collaborate cross-functionally with Marketing, Operations, and Development teams
- Develop and assess product requirements for technical coverage and subsystem integration
- Create and execute project plans and schedules
- Develop and review various product development documents
- Ensure customer satisfaction through high product quality
Skills Required:
- Bachelor’s Degree in Engineering and experience in the medical device industry
- Minimum of 10 years’ experience with engineering processes and procedures
- Proficiency in Microsoft Excel, especially in writing macros and using SmartSheet
- Experience in writing requirements using tools such as DOORS, 3DS Requirements Management (Dassault), etc.
- Strong background in documenting requirements and providing traceability documentation for FDA Approval
- Experience in configuration management and change control process/requirements is a plus
About SSi People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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