Engineer 3 - Systems

Engineer Level 3 - Systems

The systems engineer will design, develop, and integrate complex work systems for every stage of the product development lifecycle by working with a cross-functional team in multiple R&D departments. Work requires originality and judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. Performs work which requires a broad knowledge of precedents in the specialty area and good knowledge of principles and practices of related specialties. Duties are assigned to provide experience and familiarization with engineering methods, systems thinking, independent thinking, and company practices and policies. Candidates are able to plan and execute design engineering and process leadership tasks with limited guidance and oversight.

Essential duties include establishing, balancing and integrating stakeholders' goals, purpose and success criteria, and defining actual or anticipated customer needs, operational concept and required functionality. Generate and evaluate alternative solution concepts and architectures. Perform independent evaluation, selection, and application in making adaptations and modifications to projects. Receive assigned total project leadership responsibilities on a portion of major significant projects and total management responsibility for smaller projects. Manage and provide leadership for the functional group's product development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives. Implement and understand FDA or regulatory requirements as necessary. Apply technology principles to multiple tasks, using a working knowledge of cross-functional and related technical areas. Highlight risks and understand how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources. Advise team members proactively on technical ideas and promotes skill development of teamwork. Interact with peers across projects to secure resources and commitments. Handle frequent inter-organizational and outside customer contacts. Represent the organization in providing solutions to difficult technical issues associated with specific projects. Create, modify, and follow technical specification requirements and provide feedback on various technical processes and procedures. Present effectively complex technical information/analysis and respond to questions from technical staff members and management. Work cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).

Other duties and responsibilities may include work direction responsibility for technicians and other engineers. May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues. May be Lead for Technical Team or Engineering Team for technical projects. Performs other tasks at manager's request to ensure the success of project and the overall business.

Minimum qualification requirements include a Bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job. Bachelor of Science Degree in Engineering, preferred. Minimum 6 years experience, with at least 4 years progressive Engineering responsibilities. GMP manufacturing experience or laboratory experience desirable. Requires demonstrated skills in technical innovation, technical leadership, systems engineering, such as electrical, mechanical, biomechanical and/or chemical engineering, with consideration for experience in fluids engineering or cellular biology. Strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management. Strong technical problem solving skills. Demonstrate design, system modeling, risk management, requirements cascading, or related product design skills Mechanical and electronic ability aptitude to assist with equipment trouble-shooting. Understanding of and adherence to GMP practices and FDA regulations. Knowledge and ability to implement FDA or regulatory requirements as necessary. Demonstrated ability to communicate effectively both verbally and in writing. Knowledge and use of relevant PC software applications and skills to use them effectively. Performs complex technical information/analysis, and responds to questions from technical staff members regularly and effectively.

Physical requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional physical requirements include limited travel based on business needs.