Job Description

R&D Medical Device Engineer

Location: Irvine, CA

Contract, W-2

$40 - $45 an hour depending on experience

Duties:

• Applies knowledge of technical principles and company systems/procedures to maintain and optimize CC legacy/new products.
• Test and improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyzing results, making recommendations, and developing reports based on engineering principles.
• Generate work instructions, test methods, engineering drawings/prototypes, etc., to establish and characterize product and/or process specifications.
• Create and update portions of design control documents, including requirement specs and risk documents.
• Assign R&D support tasks, give instructions to technicians on conducting tests, train technicians, provide feedback, and coordinate technician work.
• Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers.
• Perform other duties as assigned by leadership.

Skills:

• Proficiency in MS Office Suite; CAD experience preferred.
• Good documentation, communication (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).
• Solid understanding and knowledge of principles, theories, and concepts relevant to engineering.
• Strong problem-solving, organizational, analytical, and critical thinking skills.
• Solid understanding of processes and equipment used in assigned work.
• Knowledge of and adherence to company 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.
• Ability to work in a team environment, including managing vendors and project stakeholders.
• Ability to build productive internal/external working relationships.
• Adherence to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and taking adequate control measures to prevent injuries to themselves and others as well as protecting the environment and preventing pollution under their span of influence/control.

Education/Experience

• Bachelor's degree in engineering required.
• 2+ years required
• Prior experience as an engineer (R&D) in a medically regulated industry (Class II or III highly preferred)
• Design verification and validation experience in the medical device industry
• Exposure to failure mode analysis.
• PPK, MLTL, or any base level knowledge of statistical tools or analysis (Minitab use).
• Test method validation
• Design verification (plans & protocols), reporting, and testing
• Data failure analysis on the design verification testing

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Job Snapshot

• Employee Type:Temp
• Location:Irvine, CA
• Job Type:Engineering
• Experience:None
• Education:None
• Date Posted:7/26/2024
• Contact: Cristina Tack (949) 620-0282
• Pay Range: $40.00 - $45.00 Hourly

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