Job Title: Medical Device Manufacturing Engineer

Starting Pay: $50-70 per hour

Duration: 3+ months

PURPOSE OF JOB : Provide assistance in the implementation and ongoing support of manufacturing lines and maintain compliance with Quality System.

MAJOR DUTIES AND RESPONSIBILITIES :

Perform, coordinate, and provide guidance on:

o Development and documentation of manufacturing processes o Design and development of assembly tooling and equipment o Process and product validations and documentation

Support of:

o Internal audits

o Supplier audits

o Material Review Board

o Complaints investigation

Analyzes returned products for failure modes and works with Quality Engineering to improve

product quality and prevent future failures

o CAPA and NCR documentation and investigation

Train manufacturing and quality staff and associates

Performs data collection and analysis to monitor trends in testing and manufacturing process results

Develop inspection and sampling plans with Quality Engineering

Develop quality metrics for manufacturing and manufacturing processes

Project team member representing Manufacturing Engineering/Development

Interface with customers representing Company

Support manufacturing activities representing Manufacturing Engineering/Development

Interfaces with outside testing laboratories and representatives from other departments

Able to read, document and understand mechanical drawings

Perform or participate in risk management analysis

Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA

regulations.

Provide support to Quality Engineering to resolve issues and provide guidance

Assist with Employee Quality System Training Programs

Create and foster a safe and inclusive work environment

EDUCATION REQUIREMENTS :

Bachelor’s degree in mechanical engineering (BSME) or equivalent with 5+ years of experience, or a Master’s degree (MS) with 3+ years of experience.

Understanding of manufacturing concepts

Good computer skills with working knowledge of Microsoft Office

SolidWorks experience a plus

Benefits:

? Health insurance

? Health savings account

? Dental insurance

? Vision insurance

? Flexible spending accounts

? Life insurance

? Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act