Sr Systems Engineer

POSITION SUMMARY:

A Sr Systesm Engineer designs a complete and complex framework, system or product. Defines processes for technical platforms, system specifications, input/output and working parameters for hardware and/or software compatibility. Conceives system interfaces and business application prototypes. Identifies, analyzes and resolves system design weaknesses. Influences the shaping of future products by contributing to the framework (architecture) used across multiple products or systems. Provides multi-layered technical expertise for next generation initiatives.

ESSENTIAL FUNCTIONS:

These may include, but are not limited to:

• Provides leadership in employing an interdisciplinary approach and applies the elements of systems engineering discipline to enable the realization of successful systems.
• Establishes, prioritizes, and documents top-level requirements for a broad range of complex and varied systems through formal analysis and client interaction.
• Operates with incomplete, ambiguous, and conflicting requirements, and drives generation of clear and actionable requirements.
• Integrates/modifies technical requirements within program constraints to develop high level system solutions.
• Analyzes requirements. Identifies concepts, architectural solutions, and system design to meet program needs (technical, schedule, budget, product cost).
• Identifies use-cases, hazards, and develops mitigations.
• Derives subsystem requirements linked to systems requirements.
• Develops verification plans and trace matrices. Executes and/or drives the verification plans. Collaborates with client in developing validation plans.
• Directs and controls the integration of hardware and software, and verifies the operation of subsystems and systems by developing and executing appropriate tests and analyses.
• Leads efforts on evaluation of system performance with respect to requirements and organizes reviews that form the basis of phase gate deliverables for the PRP phases.
• Leads cross functional efforts to identify root cause and develops system level solutions for a wide variety of product and systems challenges.
• Writes high quality technical reports independently.
• Models the life and reliability of systems/ products against requirements at each PRP phase.
• Provides systems engineering support to develop and evaluates the production specification.
• Represents the company and regularly interact with clients for new and established programs to identify technical needs and requirements.
• Provides mentorship to lower level systems engineering personnel in their development of effective systems engineering skills and capabilities, and in the application of established processes and procedures.
• Conducts and leads design reviews as appropriate.
• Collaborates closely with the Quality organization to ensure compliance with engineering, client, and regulatory requirements.
• Mentors junior systems engineers.
• Performs other job duties as required.

The functions/responsibilities outlined in this Job Description have an impact to D&K's QMS and product quality.

EDUCATION, EXPERIENCE, SKILLS AND ABILITIES REQUIRED:

Education & Experience:

Typically requires 8+ years related experience with a Bachelor's degree; 5+ years with a Master's degree; or 3+ years with a PhD, or the equivalent combination of education, experience and training that provides the required knowledge, skills and abilities. 3+ years' experience operating under a medical device / Life Sciences Quality Management System is required. Experience developing complex Life Sciences instruments is a plus.

Job Complexity:

Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise.

Knowledge, Skills & Abilities:

• Excellent interpersonal skills for collaboration and teamwork (internally and with clients).
• Excellent communication and presentation skills (written and oral).
• Recognized as a technical authority that is able to cross functional boundaries to work with all disciplines. Must be an expert in one or more areas of engineering that may include: Physics/ Optics, Electrical/ Electronic Development, Fluidic systems, Mechanical Design, Heat Transfer and Analysis, Systems Modeling and Analysis, Software Development and Implementation. Very strong grasp of fundamentals of systems engineering and development.

• An in-depth understanding of the process for capturing requirements, with an ability to employ international standards, for the formation of requirements in a sensible way.

• Familiarity with regulatory standards for medical and commercial product development aimed at the US (21CFR820), Europe (ISO 13485), and other markets, and an ability to translate them to systems and subsystems requirements.
• Well versed in formal methods for Risk Assessment including ISO 14971 risk management for Medical Devices.
• Skillful with simulation and modeling as methodology to confirm design requirements and evaluate design solutions.
• Knowledge and understanding of Hardware and Software systems and recognizes the importance of interface and data architecture to overall system performance, reliability, extensibility, and maintenance costs.
• Excellent grasp of utilizing root-cause analyses and problem solving tools (FMEA, fishbone diagrams, IS-ISNOT charts, Kepner-Tregoe problem solving, 8D problem solving, and decision making tools, etc.)
• Able to logically employ Functional Decomposition for purposes of simplifying development, reducing verification requirements, and increasing overall quality while reducing development time.
• Able to develop formal verification plans with traceability to requirements. Able to propose plans for validation and work with clients and clients to support validation of systems.
• Able to produce development phase gate deliverables that identify risks, capture additional requirements to implement mitigations, and provide appropriate verifications to reduce risks to an acceptable level for the product market.
• Able to adapt to the level of systems engineering rigor appropriate for the type of project and in alignment with client needs.
• Familiarity with using third party agencies to achieve product certification (UL, TUV, etc.)
• Write reports that serve as validation deliverables for commercial and medical device development.
• Ability to mentor other systems engineers.
• Excellent attention to details.

This is an on-site position at our San Diego location. Salary Range: $145,000 - $185,000 annually, based on experience and qualifications

Compensation is based on several factors including experience, skills, education, and job-related knowledge. In addition to base salary, Ascential Technologies offers a comprehensive benefits package.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.