Manufacturing Engineer II (Diurno 4 x 3 D - M)

Job Description:

Works on problems and projects where analysis of manufacturing processes, production performance, and operational issues requires evaluation of identifiable factors and engineering judgment. Exercises judgment within defined procedures and practices to determine appropriate actions in order to develop, implement, and sustain manufacturing processes, production controls, and engineering systems that meet company standards.

This role serves as a key technical resource supporting manufacturing operations, ensuring production lines have the documentation, tooling, fixtures, process controls, and engineering support necessary to operate efficiently. The position works closely with Operations, Quality, Regulatory, and Production teams to support validated processes, document changes, investigations, continuous improvement initiatives, and manufacturing compliance activities. The Manufacturing Engineer II also acts as a technical subject matter expert (SME) supporting production floor decisions and problem-solving activities.

Work Schedule: Diurno 4 x 3 Domingo - Miercoles 6:00 a.m. - 6:00 p.m.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Responsible for ensuring personal and company compliance with local and company regulations, policies, and procedures for Health, Safety, and Environmental compliance.

• Properly document activities in accordance with engineering best practices, company procedures, and regulatory requirements.

• Work with R&D, Design, Development, Transfer Engineers, and customers to understand products and manufacturing processes.

• Maintain and support manufacturing documentation updates and revisions.

• Evaluate customer and internal document changes to determine process impact and implementation requirements.

• Assess the impact of process, tooling, documentation, and material changes on validated manufacturing processes.

• Support engineering change control activities and implementation plans.

• Ensure production lines have the tooling, fixtures, documentation, materials, and process controls required for daily operation.

• Maintain, qualify, and monitor critical manufacturing fixtures and tooling.

• Verify fixtures and production equipment comply with specifications and validated requirements.

• Conduct engineering investigations and root cause analysis activities.

• Support yield improvement, scrap reduction, and manufacturing efficiency initiatives.

• Investigate process performance issues and implement corrective actions.

• Responsible for the development and implementation of standard manufacturing methods, process controls, and efficiency improvements.

• Conduct engineering efforts to optimize manufacturing processes through:

  • Process flow improvements

  • Time studies

  • Line balancing

  • Workflow optimization

  • Capacity improvements

• Conduct and document time studies to establish performance standards.

• Execute cost analysis activities involving labor, materials, and manufacturing burden.

• Analyze and implement improvements to reduce product costs.

• Design and improve production layouts when required.

• Support creation and implementation of new part numbers, manufacturing resources, and system updates.

• Support inventory parameter reviews, including min/max settings and manufacturing requirements within company systems.

• Participate in the design and development of equipment, tools, and fixtures that comply with company manufacturing and safety requirements.

• Set up and validate production lines for manufacturing as applicable.

• Lead and support product transfers and new product introductions.

• Support CAPA, NCR, compliance, and regulatory activities.

• Act as the Engineering SME during manufacturing floor discussions and decision-making processes involving Operations and Value Stream leadership.

• Investigate, respond to, and support resolution of quality issues.

EDUCATION AND/OR EXPERIENCE

• Bachelor's Degree in Engineering required.

• Minimum 2–3 years of experience performing engineering responsibilities within manufacturing environments.

• Experience as a Manufacturing Engineer, Process Engineer, Production Engineer, or related engineering role is required.

• Medical Device industry experience is desirable but not required.

• Candidates from other manufacturing industries will be considered if they possess relevant manufacturing engineering experience.

• Experience supporting:

  • Change Controls

  • Manufacturing Processes

  • Process Improvements

  • Yield Improvements

  • Scrap Reduction

  • Production Support Activities

• Intermediate to advanced computer skills including:

  • Microsoft Excel

  • Microsoft Word

  • Microsoft PowerPoint

  • Data analysis and reporting tools

• Statistical knowledge and data analysis experience are highly desirable.

• Lean Manufacturing, Green Belt, Black Belt, or related continuous improvement certifications are considered a plus.

• Strong English communication skills are required. Candidates must be able to participate in technical discussions and meetings conducted in English.

SKILLS AND COMPETENCIES

Manufacturing Engineering

• Strong understanding of manufacturing processes and production support activities.

• Experience with:

  • Yield Management

  • Scrap Reduction

  • Change Control

  • Process Validation

  • Production Support

  • Manufacturing Compliance Activities

• Knowledge of Quality Systems and Medical Device Regulations.

• Understanding of Process Validation, Traceability, Risk Management, and Quality Systems.

• Technical knowledge of:

  • Tooling

  • Fixtures

  • Manufacturing workflow

  • Process flows

  • Assembly operations

  • Production equipment

• Ability to serve as a Subject Matter Expert (SME) and provide technical guidance.

Continuous Improvement

Basic Quality Tools

• 5S

• Kaizen

• Pareto Analysis

• Ishikawa

• Control Charts

• Checklists

• Histograms

Professional Competencies

• Strong analytical skills.

• Strong problem-solving abilities.

• Ability to work under pressure.

• Mentoring and technical leadership capability.

• Excellent teamwork and collaboration skills.

• Accountability and ownership.

• Ability to organize, prioritize, and manage multiple assignments.

• Attention to detail.

• Strong interpersonal and communication skills.

• Self-motivated and results-oriented.

• Ability to effectively work with Operations, Quality, Regulatory, and Production teams.

• Ability to make technical decisions and provide engineering recommendations in support of manufacturing operations.

COMMENTS

This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments, and less significant responsibilities.

This role is heavily focused on manufacturing floor support, process sustainment, change control implementation, compliance activities, fixture management, and engineering support of production operations. Success in this position requires hands-on manufacturing experience, strong decision-making abilities, and the capability to work effectively with cross-functional teams in a fast-paced manufacturing environment.