Senior Process Engineer

2 weeks ago

Santa Ana, California, United States LanceSoft Full time

POSITION SUMMARY

Key Responsibilities:

  • Conduct feasibility assessments to investigate innovative catheter assembly methodologies.
  • Develop and implement strategies for equipment validation and process qualification.
  • Utilize six sigma principles, including Design of Experiments (DOEs), Gage R&R, and various statistical tools to minimize process variability.

Educational Qualifications:
Bachelor's degree in Mechanical Engineering or Bio Engineering is required.
Experience: Minimum of 4 years, preferably within the Medical Device sector.

Work Schedule:
Full-time commitment of 40 hours per week.

Location Requirements:
Position requires on-site presence.

Core Responsibilities:
Design and optimize manufacturing processes, procedures, and production layouts for various assemblies, equipment installation, and material handling. Create efficient machine arrangements within production facilities to maximize productivity.

Develop operational sequences and specify fabrication procedures for tools and equipment, impacting product performance.

Adapt machinery or equipment designs to align with production conditions. Incorporate inspection and testing requirements into production planning.

Evaluate machinery, equipment, and tools to ensure operational efficiency, addressing any issues to maintain product quality.

Formulate manufacturing processes that align with statistical process control and may innovate those techniques. Provide engineering guidance on design concepts and specifications to optimize equipment and manufacturing practices. Ensure compliance with regulatory standards.

CAREER DEVELOPMENT:
Typically an individual contributor with expertise in a specialized field. Responsible for managing and delivering assigned projects while collaborating with stakeholders to achieve objectives. May mentor junior colleagues or oversee the work of less experienced professionals.

The role primarily involves managing projects from design through implementation while adhering to established policies, leveraging specialized knowledge typically gained through advanced education.


KEY ATTRIBUTES:
Independence:
Experienced individual contributor working autonomously with minimal supervision to devise solutions. May mentor and review the work of junior specialists and manage project processes.

Organizational Contribution:
Accountable for specific projects or processes within the job scope. Plays a vital role in achieving work group goals by fostering relationships and building consensus on assignments.

Innovation and Complexity:
Challenges faced are complex and may require a comprehensive understanding of multiple disciplines. Responsible for enhancing processes, systems, or products to improve job performance. Analysis is thorough and often includes recommendations for process enhancements.

Communication and Influence:
Engages with senior internal and external stakeholders to exchange information regarding facts, statuses, ideas, and issues to meet objectives and influence decision-making.

Leadership and Talent Development:
May provide guidance, coaching, and training to peers within the job area. May oversee projects, necessitating delegation and review of team members' work.

Required Expertise:
Possesses advanced knowledge in the field, combining extensive experience with educational qualifications. Practical knowledge of project management is beneficial.

A University Degree and a minimum of 4 years of relevant experience, or an advanced degree with at least 2 years of relevant experience are required.

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