You are responsible for
Has mastery over design controls (able to mentor others).
Strong knowledge of and ability to perform Product Development Process activities.
Competent in design approaches and level of rigor good track record of successful designs.
Basic knowledge and experience with Regulatory requirements associated with design controls.
Identifies CTQ’s and KPIV’s for medium level design responsibilities.Competent in selecting the appropriate Capability Analysis to support level of rigor required for CTQ’s, KPIV’s and other specifications.
Able to initiate and conduct Design of Experiments.
Good understanding of more than one product line, including application in the field.
Conceptualizes, designs, develops and documents medium to large scale designs moderate complexity.
Develops basic catheter / disposable designs, including transducer and optical development and fabrication.
Supports optimization of existing designs.
Ability to create process maps, value stream maps, CAD drawings, and schematics.
Develops and / or guide others in statistical analysis and problem solving.Development of statistical rationale plans for development studies techniques including, but not limited to verification and validation plans, DOEs, Gage R&Rs.
Define, perform and analyze complex linear experiments and complex DOE’s.
Performs root cause analysis and implements corrective actions.
Performs development and validation of new test methods.
Direct others in design, building and testing.
Transfers new designs from R&D to production.
May be a lead on smaller design projects / components, often mentored by a Principal Level Engineer.Participates in research and / or development activities and acquires good laboratory practices (GLP).
Develops strategies and writes advanced technical reports and test plans.
Ability to generate basic test methods and procedures for evaluating designs, processes and products.
Ability to draft documentation for components, designs, processes and tools of moderate complexity.
able to perform operator training.
Assists in organizing technical design reviews and presents relevant sub-sections.
Establishes topologies and architects documentation plans for medium complexity development efforts.
Participates in development efforts as a Medical Device Development Core team representative.
Mentors technicians and junior members of the team.
Develops and conducts / manages laboratory research. Develops domain knowledge based on, and may contribute to, technical and academic literature.
Executes disposable device performance testing. Develops domain knowledge based on technical and academic literature.
Researches new materials and adapts those materials and equipment into design and production processes.
Team member or leader within functional area. Communicates with technical resources, across functional areas, outside vendors and internal customers to resolve conflicts.
Seasoned professional that provides input on various levels of projects and client requests.Independently determines and develops approaches to solutions.
Multi-discipline Domain Specific).Fully qualified, career oriented / journey-level position.
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Relies on experience and judgment to plan and accomplish goals.
Normally receives little instruction on day-to-day work, general instruction on new assignments.
May have (1-2) direct reports at the technician / operator level, but not primary responsibility.
You are a part of
A leading health technology company with a multinational workforce of approximately 77,000 employees and globally present with sales and services in more than 100 countries worldwide.
To succeed in this role, you should have the following skills and experience
or a PhD without experience; or equivalent work experience.(Mechanical Engineering, Material Science, Plastics Engineering, or Biomedical Engineering preferred).
Demonstrate organizational and interpersonal skills working in a cross-functional, regulated environment.
Understanding of theories and principles of domain (preferably in a medical setting).
Highly Desired Skills (but not required) :