The Systems Engineer will be responsible for leading the development of commercial scientific instrumentation. The SE will be responsible for executing the technical development of next generation SLIM technology. They will drive the collection of requirements from Business & Product Strategy Teams and then work to ensure that these requirements are addressed at each stage of the product development process. The engineer will follow the product development lifecycle and have experience working within a Quality Management Systems’ policies, procedures, and protocols to ensure compliance with regulatory and industry standards and practices.
- Responsible for ALL technical aspects of the product: including the instrument, accessories, and software.
- Responsible for system concept and block diagram, through prototype development until design transfer to manufacturing.
- Requirements Engineering: development and review for completeness/correctness of product definition using JAMA requirements management software.
- Responsible for Verification and Validation. Leads the activity ensuring adequate requirements test coverage, protocol and results review. This includes the creation of the verification protocol and its execution.
- Risk Management: FMEA, Product Safety, Defect Review Board(s) chair, Product change control
- Project task estimation and status reporting, accountable to the project manager.
- Lead systems level design reviews
- Strong understanding of instrumentation development in an ISO9001 environment.
- 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:
- At least 5 years’ experience with system or subsystem engineering including drafting requirements and verification activities.
- Experience leading design reviews
- 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
- Demonstrated track record of executing a product development plan from rudimentary lab prototype to commercial launch.
- Demonstrated organizational skills with the ability to handle multiple tasks with different priorities
- Ability to read and understand mechanical drawings and electrical schematics
- Bachelor’s degree in engineering, analytical chemistry, chemistry, or physics.
- Ability to work within the United States
- Willing to relocate to the Chadds Ford, PA region
Preferred Skills & Qualifications:
- Mass spectrometry instrument development experience
- An advanced degree in engineering, physics, or related discipline
- Strong project management skills
- Medical device regulatory and quality control experience
- Solid business and strategic acumen
- Successful work-related experience in leading cross-functional teams
- Proficient programming skills in one or more industry standard programming languages or firmware.
- Product development
- Product Strategy
- Business development
- Applications development
- Commercial Operations
- Mass Spec Vendors
- Scientific Community, Academic Researchers
- Manufacturers and Supply Chain Partners
Cultural, Behavioral and General Characteristics
- Work standards/high work ethic – initiative and drive
- Innovativeness & creativity
- Self-sufficient, self-driven, self-motivated (work with minimal supervision): ability to figure it out
- Ability to quickly learn SLIM technology and apply it
- Ability to think through complex issues and solve problems
- Desire to share information and support a transparent culture
- Technical translation
If interested, please send a cover letter and resume to email@example.com.
To apply for this job email your details to firstname.lastname@example.org