Job description

Technical/Functional Skills

· Ability to quickly build connections with internal and external partners

· Ability to manage multiple projects and tasks simultaneously

· Ability to read engineering drawings, GD&T, terminology, schematics

· Knowledge and experience in product development processes and design control is preferred.

· In-depth knowledge of design of medical devices preferred.

· Ability to be a technical leader on multi-functional teams

· Excellent verbal and written communication skills, including but not limited to, the ability to relate technical requirements, listen effectively, influence decision-makers by data and be able to receive constructive input from others.

· Ability to solve complex problems

Roles & Responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are:

· Must be able to perform characterization studies with statistical analysis and create test reports

· Must write process instructions, manufacturing operating procedures, and PFMEAs

· Must build equipment and setup manufacturing line(s)

· Process and run engineering WOs

· Able to travel within USA and Mexico if required to write and execute IQ/OQ/PQ

· Must be able to write and stage ECOs

· Responsible for the successful planning, coordination, execution, implementation, and timely completion of project deliverables ensuring consistency with company policies, procedures, and commitments

· Lead and drive execution of design for manufacturing including component manufacturing within the principles of DMAIC

· Ensure on-schedule and on-cost delivery of projects while managing project activities during all phases such as Engineering, Documentation, Process, Operations, Planning, etc.

· Communicate with all project stakeholders, core team, extended team, and cross-functional members

· Develop innovative workflows to generate compelling technical evidence of product or project performance under challenging conditions

· Prepare and present technical information in a clear and effective manner to project leads, managers, stakeholders

· Review and coordinate drawings, BOMs, specifications, protocols, test reports, plans, etc.

· Actively coordinate and mitigate delays within project and tasks

· Collaborate with cross-functional team, work with engineering, manufacturing, marketing and suppliers

· Ensure continued compliance of project and/or portfolio to applicable standards and regulations

· Create, track, and maintain all project documentation and progress such as Design History File, Design History Records, Engineering Change Orders, Technical File, etc.

· Follow strict adherence to policies and procedures associated with FDA and any other Notified Body (EU-MDR, PMDA, NMPA, ANVISA, etc) controlled environment

Education:

Bachelor’s degree in engineering or science (Biomedical, Mechanical, Electrical, Biology, etc)

3+ years of medical device industry experience in design control and/or project engineering

Job Types: Contract, Full-time

Pay: $100,000.00 - $110,000.00 per year

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Irvine, CA 92612: Reliably commute or planning to relocate before starting work (Required)

Experience:

• medical device: 1 year (Required)
• DMAIC: 1 year (Required)

Work Location: One location

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