Sr Prin Systems Engineer

HM's Top Needs:

1.?Experience with Requirements Management

2. Experience with Medical Device Software (at least 5 years)

3. Medical Device experience is highly preferred

Candidate will have experience in Medical Device product development. I am looking for a versatile engineer that can execute a varity of Systems Engineering tasks with an expansion into Software design history file management. The tasks included: Requirements Management, Verification Trace Matrices, Protocol Creation, Test Execution, and Report Creation. An understanding of Medical Device quality systems is ideal, with experience in Design Verification and Validation. I would like someone that can start with a list of requirements, draft a test protocol to verify each requirement, execute the testing, and write the final report.

Additionally, I would like someone that has experience with the Medical Device Software Lifecycle, specifically with the IEC 62304 Software Lifecyle Standard. I am not looking for someone to develop software, just experience with it such that they can manage our software design history files.

• 
  Experience with JAMA software would be a plus
  

Education Required: BS in engineering, Computer Science

Years’ Experience Required: 5 years minimum, 10 + Ideally

Responsibilities may include the following and other duties may be assigned. Performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems. Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal. Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy: Recognized master in professional discipline. Works independently to implement strategic goals and establish operational plans for job area. Assignments are often self-initiated. Determines and pursues courses of action necessary to obtain desired results.

Organizational Impact: Strongly influences the design of new products, processes, standards, or operational plans based on business strategy with a significant impact on functional results. Implements strategic goals established by functional leadership. Changes or may establish operational plans for job area with long-range impact on results.

Innovation and Complexity: Faces problems that span a wide range of difficulty and unique issues across functions and / or businesses which may cause redirection. Develops solutions to unique issues. Improves upon existing processes and systems using significant conceptualizing, reasoning and interpretation.

Communication and Influence: Interacts with internal and external customers and vendors at various levels, including executive leadership, on significant matters. Conducts briefings with senior leaders within the job function. Negotiates with others to reach understanding or agreement.

Leadership and Talent Management: Frequently provides guidance, coaching and training to other employees. Typically manages large, moderately complex initiatives of strategic importance to the organization, involving large cross-functional teams.

Required Knowledge and Experience: Requires mastery level knowledge of specialty area and working knowledge of several other areas, typically obtained through advanced education combined with experience. May have deep knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience.