Description

The Sr. Manufacturing Engineer is responsible for facilitating new products into production; supporting continuous improvement efforts in Operations. This position will serve as liaison between engineering, procurement, and operations on projects and a subject matter expert with operational processes, build requirements, and product/component requirements. Forward-thinking attitudes to drive cost reduction and efficiency in producing high quality assembled products in an FDA and CE medical device environment is required.

Primary responsibilities:

a) Provide design for manufacturing input throughout all phases of new product development. Evaluate product design to determine optimal manufacturing process efficiency. Estimate costs, production times, or staffing requirements for new designs.

b) Design, build and validate manufacturing and assembly tooling required to produce new products.

c) Establish the manufacturing process routing to optimize component and assembly production.

d) Develop work instructions and provide training for operators on optimized assembly processes.

e) Assures product and process quality by establishing process controls; process capabilities; establishing standards; confirming manufacturing processes.

f) Complete manufacturing engineering deliverables in the design transfer process to fulfill the Quality Management System requirements per FDA and CE requirements for medical devices. (including but not all-inclusive: DFM/DFMA, pFMEA, process mapping, process control plan, IQ, OQ, PQ validation for equipment and finished assembly, Work Instructions, Training records, calibration and GR&R).

g) Drive continuous improvement and cost reduction in design transfer and manufacturing processes. Devise new solutions to existing manufacturing challenges.

h) Troubleshoot new or existing product problems involving designs, materials, or processes. Determine root causes of failures using data and recommend changes in designs, tolerances, or processing methods. Utilize proper root cause and problem-solving techniques to drive solutions. Drive solutions that will result in consistent build excellent and profit retention.

i) Prioritize work and drive decisions to meet overall project timelines.

Skills required for success in this assignment:

a) Proficient in translating engineering design documentation into manufactured components and assembled products.

a) Experience in a manufacturing environment with knowledge in basic manufacturing processes. (for example: aluminum and steel machining, tube forming, bending, welding, finishes, and both mechanical and electrical assembly.)

b) Experience in robust Quality Management System environments (prefer Medical Devices, consider Aerospace, Defense, Automotive),

c) Skilled in developing manufacturing equipment and tooling to support product assembly.

d) Trained in Lean & Six Sigma tools.

e) Skilled in Solid Works.

f) Experience developing manufacturing methods and procedures.

g) Strong communication skills, written and verbal.

h) BS degree in Mechanical Engineering

Ferno is an equal opportunity employer and that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status.

PI277903619