Hi,


Kindly have a look below job description and let me know your available
consultant interest in this opportunity.



*Title: Systems and Equipment Staff Engineer*

*Location: Cincinnati, OH *

*Duration: 2-3 years *

*Skill Matrix:*



*Required skills*

*No. of years of experience*

*Last used year*

Lead/support NPD project to plan, design, develop, qualify, validate and
stabilize end to end assembly process solutions.





Designing and developing robust equipment and processes.





Electromechanical devices experience





Medical devices experience





Project management experience





Experience in the areas of Design for Manufacturing & Assembly (DFM & A),
Lean Manufacturing, and risk management





Experience in equipment and assembly process development in CFM (Continuous
Flow Manufacturing) environment





Experience within a medical device production environment or other health
care regulated environment.







*Job Responsibilities*

1.       Lead/support NPD project to plan, design, develop, qualify,
validate and stabilize end to end assembly process solutions.

2.       Responsible for process characterization and control for component
and assembly solutions

3.       Provide input to NPD teams on Design for Manufacturing, Assembly &
Cost and drive product development to enable robust product and process
development that meets business commitments and stabilization metrics

4.       Responsible for designing and developing robust equipment and
processes to meet product requirements in compliance to Lean, Safety and
Ergo requirements.

5.       Incorporates risk  mitigation methodology to drive  process
stability and capability

6.       Develop Verification and validation strategies for end-to end
process validation

7.       Develop methods and test solutions for product verification and
validation testing

8.       Develop robust process solutions for polymer and metallic
components, ensuring on time product launches and with low cost as a focus.

9.       Plan, conduct & direct engineering assignments to completion.

10.   Lead improvements to product quality and production processes on Life
Cycle projects

11.   Development, qualification , validation and stabilization of plastic,
metal components

12.   Apply comprehensive & diverse knowledge of engineering principles to
a broad range of assignments

13.   Write and review documentation related to procedures, special
instructions, qualification plans and reports, corrective action plans, etc.

14.   Deliver departmental goals and objectives for continuous improvement,
Financial, and franchise initiatives.

15.   Ability to function and drive  the team to execute in ambiguous
situations, with  a sense of urgency

16.   Experience working with external suppliers to drive component and
assembly process solutions.

17.   Pro-actively develop technology solutions to mitigate risk associated
with NUD product requirements.

18.   Ability to identify and translate work content associated with
process development required for NPD projects into resourcing needs.

19.   Support Project Management activities  for the Project leadership

20.   Provide leadership and mentor less experienced engineering talent

21.   Champion Systems development strategy and support operations
strategy  in end to end supply chain solution development

22.   Responsible for the process development, verification and validation
strategy and execution to the strategy.



*Qualification:*

1.       A minimum of a Bachelor's degree in Engineering is required,
preferably in Mechanical, Material Science, Bio-Engineering, or Electrical
Engineering discipline; or  a minimum of 7 years engineering experience and
a Bachelor’s degree; or a minimum of 5 years experience and a Masters
degree in product & process development is required; Prior experience in
R&D/ New product development is preferred.

2.       Experience within a medical device production environment or other
health care regulated environment preferred.

3.       Must have demonstrated success in leading individuals and
coordinating team activities, in a matrix environment.

4.       Prior project management experience required; PMP certification is
desirable.

5.       The ideal candidate will have previous experience in the areas of
Design for Manufacturing & Assembly (DFM & A), Lean Manufacturing, and risk
management (e.g. FMEA).

6.       Experience in equipment and assembly process development in CFM
(Continuous Flow Manufacturing) environment is required.

7.       Experience in the development and implementation of automated
assembly systems along with experience with PLC, HMI and Vision controls
preferred.

8.       Experience with metal component design, development, and
production processes is preferred.

9.       Experience with plastic component design, development, and
production processes is preferred.

10.   Experience in design, development, implementation and stabilization
of Measurement Systems required.

11.   Six Sigma / Process Excellence and/or Design Excellence experience is
required.  Six Sigma / Design Excellence Certification is preferred.

12.   Experience in Electro-Mechanical systems is preferred.

13.   A strong background in advanced Statistical analysis is required,
including  experience in Design of Experiments (DOE), demonstrated usage of
Process Stability, Process Control and Capability.

14.   Experience in CAD software (NX or Solid works) usage is preferred.

15.   Knowledge of GD&T (ASME Y14.5, 1994) is required for application in
NPD projects.

16.   Must be able to travel approximately 20% domestic and internationally
(including Juarez, Mexico).

17.   Strong analytical and problem solving skills.

18.   Demonstrated ability for teamwork and collaboration, strong attention
to detail and having a sense of urgency.

19.   Ability to delegate, coordinate and direct engineering assignments to
team members  and be accountable for their deliverables

20.   Understanding of SCOR model of Supply Chain is preferred.

21.   Excellent communication and interpersonal skills required.

22.   Knowledge of FDA/ISO requirements associated with the development of
medical devices, including Design Control is preferred.

23.   Understanding of IP issues relative to processes being developed
preferred.


*Let me know if needed any help from my end. You can reach me via Email:
je...@gtssminds.com <je...@gtssminds.com>, Ph: (609) 890 0316 *802*

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