Senior Engineer Job in Irving 5038, Texas US
Senior Engineer
Responsible for implementing and maintaining the effectiveness of the
quality system.
Completes professional level engineering assignments related to
complex systems development, integrating hardware, software and
potentially reagents.
Plans and conducts small to medium size assigned projects within
engineering specialty requiring conventional types of plans,
investigations and equipment.
Examples of assignments include: system, equipment or process design
and development; validation of equipment, materials and processes;
preparation of specifications. Regulatory and safety compliance.
CORE JOB RESPONSIBILITIES:
Responsible forimplementing and maintaining the effectiveness of the
quality system.
Independently evaluates, selects and applies standard engineering
techniques, procedures and criteria, using judgment in making minor
adaptations and modifications.
Conceives and develops general approaches to the solution of
engineering problems; applies a working knowledge of related
disciplines.
Compiles and evaluates design and test data, prepares technical
specifications and determines appropriate limits and variables for
product, process, or materials specifications.
Coordinates with technical support personnel to conduct prototype or
experimental runs of products or processes.
Monitors and organizes the efforts of technical and clerical support staff.
Guides the efforts of less experienced engineering staff (techs and
designers).
May provide input on potential candidates to be hired into team.
Interfaces with product team members, department managers,
designers, RD, marketing, internal regulatory.
May represent department/ division on projects or segments of projects.
Takes risks in learning
Puts self in unfamiliar or uncomfortable situation in order to learn; takes
on challenging or unfamiliar assignments; proactively seeks areas to
expand knowledge or skill.
Applies knowledge or skill
Puts new knowledge, understanding, or skill to practical use on the job;
effective in demonstrating new skills, knowledge, etc; does not persist in
ineffective behavior; Builds good relationships
Establishes good interpersonal relationships by helping people feel
valued, appreciated, and included in discussions (enhances self-esteem,
empathizes, involves, discloses, supports).
Contributes to goal accomplishment
Makes procedural or process suggestions for achieving team goals or
performing team functions; provides necessary resources or helps to
remove obstacles to help the team accomplish its goals. Willingly
accepts team assignments.
Values multiple perspectives
Values multiple perspectives and ideas. Takes independent action.
Implements new ideas or potential solutions without prompting; does not
wait for others to take action or to request action. Seeks information
Seeks out information from experts in other functional areas or
organizations to develop better methods for achieving work-related
goals.
Targets improvement ideas
Generates ideas for solutions; analyzes the effect or impact of each
solution; selects appropriate solutions.
Implements effective improvements
Develops creative improvements that are adopted by other work groups.
Tests solutions; gathers feedback on effectiveness; reviews impact on
baseline measures; modifies solutions as appropriate to ensure
effectiveness. Demonstrates honesty
Deals with people in an honest and forthright manner represents
information and data accurately and completely.
Keeps commitments
Performs actions as promised; does not share confidential information.
Behaves consistently
Ensures that words and actions are consistent; behaves consistently
across situations. Predicts patterns / trends
Grasps complexities and sees relationships among data; determines
consequences and alternatives; makes recommendations, e.g.,
develops a process improvement for manufacturing; analyzes problems
from multiple perspectives. Coordinates resources
Estimates and coordinates resources needed (materials, budget, time,
and people) to accomplish assigned individual tasks, e.g., coordinates
work with technicians and associate engineers; prepares contingency
plans and budget for assignments. Coordinates and monitors activities/
projects
Review plans and monitors status of implementation for those assigned
to project; makes judgements regarding the quality of implementation
within discipline; employs contingency plans for time make-up when
appropriate, e.g., tracks actual expenditures compared to projected cash
flow plan for own project.; Creates/modifies designs for intermediate
problems
Designs/ modifies more complexprocesses; writes detailed
design specification, e.g., creates a new production flow diagram;
modifies an existing design to improve a construction process.
POSITION ACCOUNTABILITY / SCOPE:
Receives general direction and exercises discretion as to work details.
Reviews and approves related inputs such as drawings and specs
prepared by tech support personnel.
Is responsible for completing project tasks within time and budget
constraints.
Work is reviewed for soundness of technical judgment and to determine
if desired overall results and objectives have been achieved.
Highly Desirable:
Experience in mechanical / pneumatic equipment or automation systems
(i.e. packaging or filling equipment)
Desirable:
Experience with Investigation or root cause analysis methods
General understanding of software development processes
Experience in working directly with multiple vendors to create a product
Experience with risk management - assessments, creation and
processes
Basic Qualifications:
Knowledge of regulations and standards affecting IVDs and Biologics.
Preferred Qualifications:
B.S. Engineering, ideally with a Mechanical / Electrical / Systems
Engineer focus
