Mechanical Engineer - Urgent Need

Millenniumsoft•Irvine, CA

1d•Hybrid

About The Position

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.

Requirements

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.
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.

Nice To Haves

Teamcenter also 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.

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