Mechanical Engineer - Urgent Need

MillenniumSoft Inc; Irvine (CA); Hybrid; USD 57,308,000 - 71,635,000; Full time

Job summary

MillenniumSoft Inc in Irvine, CA is seeking a Mid-Level Mechanical LCM Engineer for a 12-month contract on W2. You will support manufacturing strategy for BD APM systems and lead product and process improvements across line extensions and supplier changes.

Responsibilities include applying SIX Sigma and LEAN methods, managing change control, and developing training materials for production. This role is hybrid, 40 hours/week, with no overtime planned.

Qualifications

• Bachelor’s Degree in Engineering or Science with 5 years’ experience, or Master’s with 4 years, or PhD with field experience.
• Experience in manufacturing or medical devices is preferred.
• Strong documentation and project management skills are required.

Responsibilities

• Identify and implement opportunities to optimize manufacturing processes using SIX Sigma and LEAN.
• Support production at contract manufacturer through data analysis.
• Lead projects for material qualification, part changes, and line extensions.
• Manage change control, CAD updates, and device master records.
• Develop training and work instructions for production.
• Lead project plans to meet customer expectations.

Skills

Problem solving

Analytical thinking

Communication skills

Leadership

Documentation

Education

Bachelor's Degree in Engineering or Scientific Field

Master's Degree in Engineering or Scientific Field

Ph.D. in Engineering or Scientific Field

Tools

MS Project

Windchill PLM

Teamcenter

SolidWorks

CREO

ProE

Job description

Level of Experience : Mid-Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Position : Mechanical LCM Engineer

Location : Irvine, CA

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

pay rate: $20-25/hr

Client : Medical Devices Company

Job Category : Industrial

Level of Experience : Mid-Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT) HYBRID

NO OVERTIME planned/required

Job Description

• The (Mechanical) LCM Engineer is an exciting opportunity to collaborate on projects and initiatives in support of client Advanced Patient Monitoring (BD 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.

The Engineer’s Responsibilities Will Include

• 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

Education And Experience

• Bachelor's Degree in Engineering or Scientific field with, 5 years’ experience including either industry or industry/education Required or Master's Degree or equivalent in Engineering or Scientific field with, 4 years’ experience including either industry or industry/education Required or Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education Required

Additional Skills

• 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
• Knowledge of applicable FDA regulations for medical device industry preferred
• 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.

Preferred

• Familiarity with medical device regulations and governance documents (ISO13485, CFR820, etc.).
• Lean Champion and/or Six Sigma certifications.
• Ability to read electronics schematics and mechanical drawings.
• Experience troubleshooting and documenting evaluations of finished devices, sub-assemblies, and component failures.