Principal Systems Engineer-Hardware- Medical Device Development

Company Information:
At HiArc, we believe clients don’t need another vendor; they need a strategic partner who gets it. One who listens harder, thinks deeper, and builds smarter—around their needs, products, and goals. HiArc engineers and manufactures complex medical technologies with one goal in mind: creating the perfect fit for our clients. No off-the-shelf thinking. No compromises. Just a tailored, high-performance solution our clients need, the way they need it. That’s why HiArc is the most client-centered partner in the market. We fuse design, engineering, and manufacturing into a seamless, collaborative process—crafted entirely around our clients. We operate as an extension of our clients' teams, de-risking their processes and accelerating their path to market. And the result is a solution you won’t find anywhere else.

Join our team! We hire experts in hardware and software design, robotics, optics, fluidics, chemistry integration, motion and thermal control, risk management, supply chain management, performance testing, advanced manufacturing techniques, finance, human resources, sales, and marketing.

For more information, please visit HiArc.

This is an advanced level individual contributor position responsible for solving a variety of technical problems of considerable complexity. Plans, conducts, and technically directs projects or phases of significant projects, coordinating the efforts of technical support staff in the performance of assigned projects. May provide technical consultation to other organizations, work leadership of lower level employees, and make recommendations to management of a technical nature. Must have advanced knowledge of accepted principles and techniques within the systems engineering discipline

Responsibilities:

• Solve a variety of engineering problems involved in the design and development of products, equipment, or processes. May design and layout complex items. Consults with higher level engineering personnel to resolve more complex design alternatives.
• Develop specifications against which designs can be produced. Translates experimental results into design criteria.
• Assist with portions of engineering projects or programs, the formulation of design criteria, or performing analysis of engineering data to select the best technical approach. Specifies phases of tests, investigation or analysis.
• Assist manufacturing in transition from development into production.
• Determine appropriate materials and processes for specific applications.
• Prepare engineering specifications for purchases.
• Fabricate engineering approval models and prototypes.
• Conduct field testing and research work for new applications.
• Assist in preparing cost estimates on proposed major design products.
• Ensure that sound scientific principles are applied in laboratory or pilot plant work.
• May assist in troubleshooting customer application problems.
• Provide direction to technicians.
• Develop reliability models for electromechanical, electro-optical sub-assemblies and assemblies.
• Ensure component reliability based on technical evaluation of vendor's designs and manufacturing processes.
• Lead System Integration, Verification, Validation and Certification by defining, specifying and supervising testing, analysis, Installation and integration activities and preparing reports to document the results of such activities.
• Perform other related duties as assigned.

Qualifications:

• Bachelor's Degree in engineering or equivalent scientific discipline with 8 or more years of experience to be proficient in the above areas. Incumbents should possess a broad knowledge of precedents in their area of technical specialization and a good basic knowledge of principles and practices in related specifications.
• Experience in an FDA-regulated environment is essential
• Advanced DOORS requirements management training
• Systems Engineering Simulation and Modeling concepts
• Systems Engineering methods and procedures

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Here Are Some of the Great Benefits We Offer:

• Most locations offer a 9/80 schedule, providing every other Friday off
• Competitive compensation & 401(k) program to plan for your future
• Robust medical, dental, vision, & disability coverage with qualified wellness discounts
• Basic Life Insurance and Additional Life & AD&D Insurances are available
• Flexible Vacation & PTO
• Paid Parental Leave
• Generous Employee Referral Program
• Voluntary Benefits Available: Longer Term Care, Legal, Identify Theft, Pet Insurance, and more
• Voluntary Tricare Supplement available for military retirees

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This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. The employer has the right to revise this job description at any time. The job description is not an employment contract. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. HiArc, an Elbit America company, is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.