Systems Engineer (R&D)

Job responsibilities:

Participates on project teams to develop clear specifications, evaluates feasibility of concepts, and provides formal estimates for control systems and equipment integration system designs.

Develop applications on-prem/cloud (device -to-device communications or device-to-cloud communications) and selection of specifies control components that support production and machine integration.

Designs control systems and (PC and PLC based) solutions.

Coordinates, monitors and documents project designs, estimates, and costs. Complete project deliverables and monitor project schedule and scope changes to assure the team can meet delivery requirements.

Prepares standard reports/documentation to communicate status and results. Deliver data-driven insights, produce timely and actionable information to help drive business results through effective dashboards and visualizations

Member of project teams that include Designers, Engineers and Technicians in the design, assembly, and debug of issue.

Opportunity to learn or implement industrial controls software.

Influences and defines functional, departmental/divisional procedures through involvement with cross-functional engineering initiatives.

Provides training as required to ensure that the solutions can be operated effectively

Collaborate with internal stakeholders to elicit requirements and transform them into technology solutions.

Incident Management: Manages Equipment failure outlining impact on the business, recovery plan, and resources required.

Ensure best software practices are employed by the group so as to maximize equipment effectiveness.

Determines appropriate skills in order to meet the plant software development requirements.

Ensures compliance with Software Validation/Control policies, and procedures.

Ensures compliance with Equipment Engineering procedures.

Provides software support to the Equipment Design, Maintenance, and Manufacturing groups.

Reviews software design specifications and associated documentation for equipment and systems.

Familiar with all aspects of software validations and 21 CFR Part 11Issues for electronic records and signatures.



Job Requirements:

Candidate process at least Bachelor’s degree in Biomedical Engineering, Electrical Engineering or related field (computer, software, systems)

At least 5 years in product development

Proficient with system engineering principles

In depth knowledge of design verification for a regulated industry

Proficiency with lab equipment including power supplies, oscilloscopes, multimeters, spectrum/signal/logic analyzers

Effective communications/presentation skills to all levels of the organization (both written and verbal)

Experience working within Design Controls or equivalent for Medical Device Industry

Electrical safety (IEC 60601-1), HF (IEC 60601-2-2) and EMI/EMC (60601-1-2) standards experience

10-20% travel, including international

Preferred Qualifications:

Medical device experience

Master’s or Ph.D degree in Biomedical Engineering, Electrical Engineering or related field (computer, software, systems)

Clinical and technical knowledge of imaging based medical devices

Proficient with electrical engineering, optics and bioinstrumentation principal