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MillenniumSoft Inc · 1 month ago

Mechanical LCM Engineer - Urgent Need

Irvine, CA

Full-time

Onsite

Mid Level

4+ years exp

MillenniumSoft Inc is a company specializing in medical devices, and they are seeking a Mechanical LCM Engineer to support their Advanced Patient Monitoring systems. The role involves optimizing manufacturing processes, leading initiatives for project improvements, and ensuring compliance with industry standards.

Staffing & Recruiting

No H1B

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

Review all incoming PCNs and assess any changes (material, mechanical, electrical, datasheet, etc.)

Route PCNs with relevant changes to designated product owners

Maintain a tracking system for PCNs reviewed, routed, and approved. Collaborate with the team to refine triage criteria and improve efficiency

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, audit observations)

Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes

Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)

Other incidental duties assigned by Leadership

Qualification

Mechanical CAD toolsLean methodsSix SigmaWindchill PLMMS Office SuiteProject management toolsStatistical techniquesAnalytical skillsCommunication skillsProblem-solving skillsOrganizational skillsLeadership skillsInterpersonal skills

Required

Bachelor's Degree in Engineering or Scientific field with 5 years' experience including either industry or industry/education Required

Master's Degree or equivalent in Engineering or Scientific field with 4 years' experience including either industry or industry/education Required

Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education Required

Proven expertise in usage of MS Office Suite including MS Project

Proven expertise/knowledge using Windchill PLM. Teamcenter also preferred

Ability to use Mechanical CAD tools (SolidWorks, CREO, ProE)

Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

Basic understanding of statistical techniques

Previous experience working with lab/industrial equipment (if applicable)

Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering and best practices

Strong problem-solving, organizational, analytical and critical thinking skills

Substantial understanding of processes and equipment used in assigned work

Good leadership skills and ability to influence change

Knowledge of and adherence to BD Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

Strict attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment

Must be able to work in a team environment, including inter-departmental teams

Be a key contact representing the organization on contracts or projects with suppliers

Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others