Smith+Nephew

Medical Devices

Sr.ManufacturingEngineer

Alajuela, Costa Rica FULL TIME Remote Friendly
The Brief

“Sr. Manufacturing Engineer at Smith+Nephew. Skills: Manufacturing Engineering, Process Improvement, Quality Compliance. Provide sustaining engineering support. Ensure process stability”

What You'll Achieve.

Achieve annual corporate objectives; Contribute to positive financial results; Ensure proper implementation; Ensure process stability; Ensure regulatory compliance; Achieve departmental objectives; Achieve corporate objectives

Industry & Context.

Medical Devices
Problems you'll solve

Root cause analysis; Resolve manufacturing issues; Resolve process issues; Resolve product issues; Resolve equipment issues

Eligibility Requirements

Weight Handling: Medium (5.1 kg – 30 kg), Working Position: Approximately 50% seated / 50% standing, Repetitive Motion: Low (<10 movements per 30 seconds), primarily computer use, Chemical Exposure: Occasional use of chemicals throughout the day, Physical Risk / PPE: Occasional use of Personal Protective Equipment (PPE) required

What They're Looking For.

Must Have

Bachelor’s degree in Engineering (Mechanical, Electrical, Materials, Industrial, Electronic, or Electromechanical Engineering), 5 years of experience for Bachelor’s degree holders, 4 years for Licentiate degree holders, 3 years for Master’s degree holders, 1 year for Doctorate degree holders, Proficiency in MS Office tools (Word, Excel, Outlook) and Minitab, Knowledge of Good Manufacturing Practices (GMPPM), 5S, and Lean Manufacturing methodologies, initiative, proactivity, and adaptability to change, High level of leadership skills (mandatory), Ability to work under pressure in a fast-paced manufacturing environment, people management, communication, and interpersonal skills, Ability and willingness to work effectively in cross-functional teams, Solid understanding of statistics, sampling plans, dimensional tolerances, inspection methodologies, and GR&R analysis, Spanish and English – fluent verbal and written communication

Nice to Have

Lean Manufacturing or Six Sigma certification (Green Belt preferred), Process Validation certification or formal training (IQ/OQ/PQ), Certified Quality Engineer (CQE) or Quality-related training (ASQ or equivalent), Project Management training or certification (PM fundamentals, PMP coursework, or equivalent), Training or certification in Statistical Process Control (SPC) and GR&R analysis, SolidWorks or CAD software training/certification, GMP (Good Manufacturing Practices) training within regulated industries (Medical Devices preferred), Preferred experience in the medical device manufacturing industry, Experience using project management tools (Project Manager – desirable, not mandatory), Desirable technical knowledge in Lean Manufacturing, process validations, protocol creation, process transfers, SolidWorks, SPC, and statistical tools (Minitab)

What You'll Do.

Provide sustaining engineering support

Ensure process stability

Ensure product quality

Ensure regulatory compliance

Drive continuous improvement initiatives

Resolve manufacturing issues

Support cost objectives

Support efficiency objectives

Support delivery objectives

Execute equipment validations

Execute fixture validations

Execute process validations

Analyze process improvements

Implement process improvements

Provide technical support to production

Perform root cause analysis

Resolve process issues

Resolve product issues

Resolve equipment issues

Maintain communication with shop floor personnel

Train manufacturing personnel

Coach manufacturing personnel

Support process transfers

Create manufacturing documentation

Maintain manufacturing documentation

Control manufacturing documentation

How You'll Work.

Team & Collaboration

Collaborate closely with the Quality department; Lead and collaborate with cross-functional teams; Work effectively in cross-functional teams

Communication Scope

Excellent communication skills; Fluent in English and Spanish (written and spoken); Fluent verbal and written communication

Process & Methodology

Project Management training, Project Management certification, PM fundamentals, PMP coursework, Project execution

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