Senior Systems Engineer

Support product development efforts as a key member of program teams by leading systems engineering tasks defining, developing or validating a smaller program or several features on a major program.

MAIN RESPONSIBILITIES

•Gathers, understands, and analyzes input requirements from stakeholders for new medical devices while supporting the instrumentation/service infrastructure. Translates information into specific system features.

•Synthesizes all gathered information together with technical and regulatory constraints in order to define a system and its behavior resulting in defining a system specification.

•Assists in determining clinical priorities for new products.

•Performs technical planning and performance evaluation studies, conducts technology assessment activities, analyzes system integration issues, generates initial baseline interface specifications, estimates costs and risk, and evaluates customer satisfaction through testing (alpha and beta), analysis and studies.

•Assign projects to specific teams and determine how systems will be architected and implemented. Provides guidance and leadership to teams as appropriate.

•Evaluates prototypes formally and informally through structured and ad hoc testing. Test aspects of new projects or algorithms to evaluate prototypes and validate output to meet intended use requirements.

•Provides input into the development of system verification plans and the conduct of those tests.

•Identifies and resolves issues, escalating as appropriate.

•Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

•Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

QUALIFICATIONS

Education

Education Level

Major/Field of Study

Or

Education Level

Bachelors Degree ( 16 years)

Biomedical Engineering, Electrical Engineering, a related engineering field, or equivalent, including relevant coursework and/or work experience in product development. 

an equivalent combination of education and work experience

Experience/Background

Experience Details

Minimum 6 years

Relevant, progressively more responsible work experience in medical product development and/or a graduate degree with relevant project experience.

Demonstrated ability to apply an expert understanding of clinical application to issues in order to bring tasks to resolution within assigned projects. Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. Medical device industry experience preferred. Advanced credential in a relevant discipline/concentration, including Biomedical Engineering, preferred. Professional certification or designation preferred. Training and experience in manufacturing processes and methods preferred.

Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.

Ability to travel approximately 5%, including internationally.

 

The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.]]><