Principal Systems Engineer - In Vitro Diagnostic Device Development (REF1893D)

Company Description

KMC Systems, an Elbit Systems of America company, offers an ecosystem of engineering and innovation to develop the most advanced clinical and operational solutions for leading medical device customers across a diverse range of market segments. KMC was established in Merrimack, NH, in 1980, conveying almost half a century of innovation, R&D of next generation devices, and the agility to evolve to meet changing market dynamics. This has kept KMC at the forefront of technological advancements and as the premier choice for leading global medical device and healthcare companies. KMC is a full-suite provider with services in: Engineering Design, Manufacturing, Product Ideation, Product Lifecycle Management, and Sustaining Engineering.

We are looking for extraordinary people to join #OneTeamOneMission to create and deliver innovative solutions that protect and save lives

Job Description

The Systems Engineer translating the products user needs into system requirements, define system architecture and complete systems analysis (design tradeoffs, throughput and product risk). Systems engineers along with other discipline engineers develop the instrument and various module designs, test and refine the designs and verify them to the requirements before release to production.

The System Engineer helps to ensure that the regulatory requirements are satisfied, address the product and technical risks as they arise throughout the program. The Systems Engineer maintains close interaction with product owners to ensure we are delivering the product that meet the customer’s needs.

 Responsibilities

• Lead effort to create system level concepts & analysis for new project proposals. Review and critique concepts created by proposal team.
• Ability to prepare Systems Engineering cost and schedule estimates on major design development efforts. Provide technical presentation support and consultation to Business Development Team for proposals and during development.
• Plan and lead engineering testing to evaluate operating characteristics of products or processes. Translate test data into design requirements and criteria.
• Work with the various engineering disciplines to develop the instrument or module design will meet the system/ module requirements
• Lead Technical Design Reviews at various stage of development to insure the conceptual/ detailed approach and the various supporting analysis will lead to a design that meets requirements.
• Contribute to System Integration, and lead Design Verification by defining, specifying and supervising testing, analysis and integration activities. Ensure reports are prepared to document the results of such activities.
• Support the design review and phase gate process to ensure that engineering deliverables are at the appropriate level to meet FDA/ISO requirements & standards.
• Accountable to oversee the development of requirements for different disciplines such as Software, Electrical, Mechanical, Electro-optics and others. 

Qualifications

• Bachelor’s Degree in Engineering
• 9 years of complex electro-mechanical instrument systems engineering experience
• Hardware / software integration experience.
• Must be available for daily onsite presence

Preferred Requirements:

• Master’s degree in Engineering.
• Medical Device experience
• Extensive development experience in at least one or more of the following engineering disciplines is required: software, mechanical, electrical, optics, fluidics and should possess knowledge of advanced theories, concepts, principles, and processes.
• Ability to provide technical leadership as required during the investigation of complex medical instrumentation products. Accountable to oversee the development of requirements for different disciplines such as Software, Electrical, Mechanical, Electro-optics and others.

Additional Information

Here Are Some of the Great Benefits We Offer:

• Most locations offer a 9/80 schedule providing every other Friday off
• Competitive compensation & 401k 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 many more options
• Voluntary Tricare Supplement available for military retirees

It has been and will continue to be the policy of Elbit Systems of America to recruit, hire, train, and promote into all job levels based solely upon job-related qualifications without regard to race, color, religion, creed, age, sex, national origin, gender identity or expression, sexual orientation, disability, marital status, veteran or military status, genetics or citizenship status. 

EEO STATEMENT:

Elbit Systems of America is proud to be an Equal Opportunity Employer of Minorities/Females/Protected Veterans/Individuals with Disabilities/Sexual Orientation/Gender Identity. Your information will be kept confidential according to EEO guidelines.

ACCESSIBILITY:

Elbit Systems of America is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email [email protected].

#LI-SW1

#LI-Onsite