Electro-Mechanical LCM Engineer

Lancesoft; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Lancesoft is seeking an Electro-Mechanical LCM Engineer to collaborate across product development and manufacturing teams in Irvine, CA. You will contribute to advancing patient monitoring systems by optimizing processes, leading change initiatives, and ensuring compliance with quality systems.

Responsibilities include designing experiments, qualifying manufacturing methods, and developing documentation for knowledge transfer.

Qualifications

• Bachelor's degree in engineering or a related field with applicable experience.
• Advanced degrees preferred for higher responsibility roles.
• Experience in medical device or highly regulated manufacturing environments is a plus.

Responsibilities

• Identify and implement opportunities to optimize manufacturing processes using SIX Sigma and LEAN methods.
• Lead initiatives to support manufacturing projects including changes to parts, processes, and equipment.
• Manage change control processes: CAD updates, process changes, device master records, and product specs.
• Develop experiments and tests to qualify and validate processes, analyze results, and report findings.
• Establish project plans and use risk analyses to ensure on-time deliverables.

Skills

Windchill PLM

SolidWorks

Creo

Pro/ENGINEER

Mechanical drawings

Statistical methods

Cross-functional teams

Technical writing

Quality systems

Problem solving

Education

Bachelor's degree in engineering or related field

Master's degree in engineering or related field

PhD in Engineering or related field

Tools

Windchill PLM

Teamcenter PLM

SolidWorks

Creo

Pro/ENGINEER

Microsoft Project

Job description

The Electro-Mechanical LCM Engineer is an exciting opportunity to collaborate on projects and initiatives in support of Client s Advanced Patient Monitoring (Client APM) systems. This position will play a key role in the development and execution of the manufacturing and operations strategy, including supporting key projects and initiatives, ongoing manufacturing, new product commercialization, line extensions, interfacing with third party providers, and leading product and process improvements.

Responsibilities

• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.G., SIX Sigma and LEAN methods) employing technical design skills to re-design/design to ensure parts, equipment, tools, fixtures, etc. Are up to standards Use technical principles, problem solving skills, and data analysis to support and problem-solve for production at contract manufacturer.
• Work and lead initiatives to support manufacturing projects and goals (material qualification, supplier/label/part/product changes, product enhancements, equipment qualifications, tolerance stack analysis through technical advancements, problem solving skills, and process excellence methodologies.
• Support key project initiatives (supplier transfers, part changes, system enhancements, line extensions, cost reductions, labor efficiency improvements, and quality and compliance excellence).
• Manage change control for ongoing manufacturing changes, including CAD updates, change requests, process changes, Device Master Record, product specifications, test processes, and product service processes.
• Deploy, review, and act upon meaningful metrics to measure, control, define, refine, and optimize processes and for process control and continuous improvement.
• Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes;analyze results, make recommendations, and develop reports Analyze and resolve complex manufacturing and compliance issues (e.G., CAPA, non-conformances, and audit observations) Develop training and documentation materials (e.G., work instructions) for production to enable seamless knowledge transfer of project and manufacturing processes Lead and establish project plans to ensure deliverables are completed to customer expectations using project management tools (e.G., project plans and risk analyses) Perform other incidental duties as assigned by leadership

Education and Experience

• Bachelor s degree in engineering or a related scientific field with at least 5 years of relevant industry or combined industry and academic experience;
• or Master s degree in engineering or a related scientific field with at least 4 years of relevant industry or combined industry and academic experience;
• or Ph.D. In Engineering or a related scientific field with relevant industry or academic experience.

Required Skills

• Proficiency with Microsoft Office applications, including Microsoft Project
• Ability to read electronic schematics and mechanical drawings
• Experience with Windchill PLM
• Experience with mechanical CAD tools such as SolidWorks, Creo, or Pro/ENGINEER
• Strong technical writing, documentation, presentation, and verbal communication skills
• Demonstrated analytical, problem-solving, critical-thinking, and organizational skills
• Demonstrated strong accountability and ownership, with a proven ability to take responsibility for commitments, proactively drive work to completion, and follow through on deliverables
• Working knowledge of statistical methods, engineering principles, manufacturing processes, process controls, and production equipment
• Ability to manage multiple priorities and work effectively with cross-functional teams in a fast-paced environment
• Demonstrated ability to lead initiatives, influence change, and collaborate with internal teams, suppliers, and senior stakeholders
• Strong attention to detail and commitment to quality, compliance, and workplace safety

Preferred Skills

• Experience with Teamcenter PLM
• Familiarity with medical device quality systems and regulations, including ISO 13485 and 21 CFR Part 820
• Lean Champion or Six Sigma certification
• Experience troubleshooting finished devices, subassemblies, and component failures and documenting evaluation results
• Experience with clean-room manufacturing, laboratory, or industrial equipment