Advanced Manufacturing Engineer
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As our Advanced
Manufacturing Engineer your Key Accountabilities will include:
- Work
as part of the development team to bring new products to market on time;
in budget and within predetermined specifications.
- Is
a core team member on the product development process (PDP) teams representing operations (Eng.,
Mfg., Procurement, Logistics) and is accountable for leading manufacturing
core teams during the different PDP phases.
- Accountable
for key operations related deliverables within the (PDP) including but not
limited to Mfg Plan; Make/Buy decision analysis/recommendation; Capacity
Planning; COGS estimation; Process Validation; Prototype Builds; Capital
Equipment Specifications and Procurement; etc.
- Accountable
for the application of Design for Excellence (DFX) principles such as DFM;
DFC; DFQ; DFT.
- Application
of OpEx methodologies such as Six Sigma and LEAN to identify, validate and
improve defect sources in a variety of business processes.
- Application
of risk management methodologies such as DFMEA and PFMEA to identify
actions that can be taken to eliminate or reduce the potential causes
leading to failures.
- Adhere
to SOP’s and have the ability to prepare written policies, procedures,
proposals, and reports in accordance with cGMP/FDA/ISO-13483 guidelines
and regulations.
As Advanced
Manufacturing Engineer your Skills & Qualifications will include:
Minimum
requirements;
- As
our Advanced Manufacturing Engineer your Key Accountabilities will
include:
- Work
as part of the development team to bring new products to market on time;
in budget and within predetermined specifications.
- Is
a core team member on the product development process (PDP) teams representing operations (Eng.,
Mfg., Procurement, Logistics) and is accountable for leading manufacturing
core teams during the different PDP phases.
- Accountable
for key operations related deliverables within the (PDP) including but not
limited to Mfg Plan; Make/Buy decision analysis/recommendation; Capacity
Planning; COGS estimation; Process Validation; Prototype Builds; Capital
Equipment Specifications and Procurement; etc.
- Accountable
for the application of Design for Excellence (DFX) principles such as DFM;
DFC; DFQ; DFT.
- Application
of OpEx methodologies such as Six Sigma and LEAN to identify, validate and
improve defect sources in a variety of business processes.
- Application
of risk management methodologies such as DFMEA and PFMEA to identify
actions that can be taken to eliminate or reduce the potential causes
leading to failures.
- Adhere
to SOP’s and have the ability to prepare written policies, procedures,
proposals, and reports in accordance with cGMP/FDA/ISO-13483 guidelines
and regulations.
As Advanced Manufacturing Engineer your Skills &
Qualifications will include:
Minimum
requirements;
- BS
Degree in Mechanical Engineering
- A
minimum of 10 years manufacturing engineering experience in a medical
device, pharmaceutical or related industry, with a demonstrated track
record of developing processes for new products including experience in
Plastics Processing Mfg. Technologies (Moulding, Extrusion, Assembly of
consumable medical devices)
- Strong
record of manufacturing (mfg) operations management experience including:
a) mfg. process management involving a collection of
technologies and methods used to define how products are to be manufactured
b) end-to-end manufacturing process involving production
management, performance analysis, quality and compliance.
- Knowledge
of raw materials, production processes, quality control, costs, and other
techniques for maximizing the effective manufacture and distribution of
goods.
- Experience
with industrial engineering processes including takt/cycle times
estimates, process flow, line layout, capacity planning.
- Strong
Project Management Skills of manufacturing process from concept to
delivery.
- Knowledge
of business and management principles involved in strategic planning,
resource allocation, leadership technique, production methods, and
coordination of people and resources.
- Strong
Mechanical Aptitude (aptitude for understanding and using machines and/or
tools).
Preferred
requirements:
- Six
Sigma/Lean certified preferred.
- Ability
to prepare written policies, procedures, proposal, and reports.
- Well
versed in Design for Excellence (DFX) Principles.
- Knowledgeable
in risk management methodologies such as DFMEA and PFMEA.
- Knowledgeable
in manufacturing plant test strategies.
Other
skills:
- Machining
equipment experience preferred.
- Solid
Works, AutoCAD, MS Office, MS Project.
- Effective
communication skills with superiors, peers and subordinates
.
