Manufacturing Engineer 4

Job description

Primary Function of Position Sr. Manufacturing Engineer is responsible for supporting production released assembly lines for instruments and accessories. Plan and deliver improvements in reliability, cost, manufacturability, and serviceability. Lead a team of Engineers as well as cross-functional teams, providing support in product/process documentation and criteria; as well as in mechanical, electrical and electronics disciplines.

Contribute with his/her technical skills in the areas of manufacturing, problem solving and training. Lead and schedule production line transfers.

Essential Job Duties

Lead and participate in initiatives focused on yield improvement, material cost reduction. Create budget estimates for Equipment, Fixtures and Tools, prototype designs and first article activities. Equipment, Fixtures and Tools reliability challenge and provide design improvements proposals. Equipment, Fixtures and Tools specification, documentation, procurement, maintenance, qualification, and implementation. Manufacturing assembly line reliability and layout improvements, including proper line balance.

Provide Design Engineering input for Design for Manufacturability (DFM) to ensure standardization across the assembly product and processes.

Creation, revision and/or approval of manufacturing and engineering documentation, including: Engineering Change Orders (ECO's, BCO's, NCO's, MCO's, etc.)

• Work instructions (MPI's, IVI's, Acceptance criteria, etc.) Operating procedures (SOP's, DOP's, etc.)
• Take responsibility for developing and maintaining compliance with the quality system.

Address production line support as issues arise. Document (investigate, address root cause, and report) any variances, or concerns on all aspects of the manufacturing process through current notification processes (VR's, NCR's, PL's, etc.) Review, provide technical support and assign disposition to discrepant material or products and implement corrective actions to prevent recurrence. Evaluate and select suppliers for mechanical parts.

Help resolve supplier quality issues. Involved in assembly lines or products transfers into our facilities, including planning, validation/verification and final implementation. Performs other duties as required.

Travel

Position may require 5-10% travel, primarily within The United States.

Qualifications

Required Skills and Experience

Be of high character and energy with regard for detail. Demonstrate Mechanical and/or Process Engineering ability. Demonstrate ability in failure analysis and continuous improvement. Minimum 5 - 8 years mechanical or manufacturing engineering experience with Mid/high volume complex mechanism manufacturing. Able to read and understand mechanical and electrical drawings. Solid modeling experience (ProE, SolidWorks, or equivalent).

Possess strong communication skills to interact with suppliers, other departments within the company (product development, planning, purchasing, regulatory, quality, etc.) Prior experience with various sensor applications and technologies, including reliability and performance assessment. Demonstrated ability to effectively design experiments. Prior responsibility for process, equipment, or product validation/verification.

Prior experience with automated equipment, complex mechanism manufacturing, or robotics. Experience with ASME Y14.5 Geometric Dimensioning and Tolerance. Experience in Just-In-Time, Demand Flow Technology, and Lean Manufacturing techniques. High English level(+ 80 %). Required Education and Training BS degree in Mechanical Engineering or equivalent. Working Conditions None

Preferred Skills and Experience

MS in an engineering discipline preferred. Prior experience working in an FDA/ISO regulated environment. Experienced in ISO 13485 or medical device manufacturing environment preferred.