Systems Engineer

Posted 20 Days Ago
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Chadds Ford, PA
Mid level
Biotech
The Role
The Systems Engineer will lead the development of SLIM ion mobility instruments, managing requirements, system architecture, and ensuring compliance with standards throughout the product lifecycle.
Summary Generated by Built In

Position: Systems Engineer

Reports to: Engineering Manager

Position Location:Company HQ in Suburban Philadelphia, PA

The Systems Engineer (SE) will be responsible for leading the development of the next generation of SLIM based ion mobility instruments coupled with LC-MS. This multi-disciplinary role requires basic technical knowledge across electrical, software, and mechanical engineering. The Systems Engineer will drive the collection of requirements from the business & technical teams and then work to ensure that these requirements are addressed at each stage of the product development process. The systems engineer will follow the product development lifecycle and operate within the Quality Management Systems’ policies, procedures, and protocols to ensure compliance with regulatory and industry standards and practices.  

Responsibilities:

  • Facilitate requirement collection from business and technical teams
  • Derive, manage, and drive the review of product, system and subsystem requirements across functional groups.
  • Responsible for system concept and architecture diagram.
  • Participate in design reviews for all subsystem components.
  • Responsible for system integration and verification to ensure that requirements are met.
  • Responsible for configuration management of the product during development.
  • Responsible for product FMEA, Safety, and change control.
  • Responsible for product life cycle and sustaining engineering.
  • Adhere to MOBILion’s QMS policies, procedures, and protocols to ensure compliance with regulatory and industry standards and practices.  
  • Create plans, procedures, protocols, and reports to support product development lifecycle and stage gate review.
  • Lead external safety and environmental regulatory certifications.
  • Work with manufacturing and service personnel to improve quality, cost, manufacturability, and serviceability of products.

Required Skills & Qualifications:

  • Bachelor’s degree in engineering (Electrical, Software, Mechanical, Chemical).
  • At least 3 years’ experience with system or subsystem engineering including drafting requirements and verification activities.
  • Experience with complex products involving mechanical, electrical, and software systems.
  • Strong written and oral communication skills.
  • Strong understanding of product development in an ISO9001 environment.
  • Detail oriented documentation skills
  • Strong product design skills and troubleshooting ability.
  • Excellent group interaction and negotiating skills.
  • The ability to lead the product development from lab prototype to commercial launch.
  • Ability to read and understand mechanical drawings, electrical schematics, and source code.

Preferred Skills & Qualifications:

  • An advanced degree in engineering, physics, or related discipline
  • Mass spectrometry instrument development experience
  • Strong project management skills
  • Medical device regulatory and quality control experience
  • Successful work-related experience in leading cross-functional teams
  • Proficient programming skills in one or more industry standard programming languages.

Key Relationships

  • Internal Interactions: Product Management, Product Development, Applications Scientists, Research and Development, Manufacturing, Field Service
  • External Interactions: Mass Spec Vendors, Scientific Community, Academic Researchers, Manufacturers and Supply Chain Partners

Cultural, Behavioral and General Characteristics

  • Integrity
  • Collaborative
  • Work standards/high work ethic – initiative and drive
  • Innovativeness & creativity
  • Self-sufficient, self-driven, self-motivated (work with minimal supervision)
  • Curiosity
  • Ability to quickly adapt and learn
  • Ability to dissect complex problems into small resolvable issues

Top Skills

Electrical Engineering
Iso9001
Mass Spectrometry
Mechanical Engineering
Software Engineering
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The Company
Chadds Ford, PA
78 Employees
On-site Workplace
Year Founded: 2015

What We Do

MOBILion’s technology makes it easy to separate, identify and analyze the most challenging molecules that other instruments fail to detect. Our higher resolution, faster analysis and simpler workflows reveal molecules that are most important in characterizing biologic therapeutics, discovering biomarkers, and improving the accuracy of diagnostic tests. We make today’s treatment’s safer and more effective, empower tomorrow’s disease prediction and diagnosis, and accelerate the development of new therapies.

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