R&D Engineer

Summary:
Design and develop drug combination products, applying engineering principles, SolidWorks expertise, and process validation knowledge within the medical device industry.

Requirements:

• BS in Mechanical or Biomedical Engineering
• 5+ years of experience in medical device product development
• Hands-on experience with SolidWorks
• Knowledge of process validation, including IQ/OQ/PQ
• Understanding of US regulatory and quality requirements such as 21CFR820.30

Preferred Skills:

• Exposure to combination products
• Master’s Degree in a relevant field
• Experience with Factory Acceptance Testing
• Proficiency in GD&T
• Familiarity with tooling and process validation methods

Job Responsibilities:

• Design and develop drug combination products
• Utilize statistical tools, computer analysis, and engineering fundamentals to solve complex problems
• Apply design for manufacturing principles and geometric dimensioning and tolerance (GD&T) tools to create engineering drawings
• Identify the best tools and approaches to solve engineering challenges
• Develop, optimize, and analyze designs using analytical and experimental methods
• Evaluate and assess new technologies, intellectual property, products, and processes
• Support current products in quality, manufacturing, and cost improvement efforts
• Execute technical and cross-functional project work
• Write detailed technical reports based on design verification testing
• Develop and implement test methods
• Create realistic and actionable design plans
• Collaborate with laboratory technicians and support staff
• Ensure compliance with quality policies, standard operating procedures, and regulatory practices

Pay Details: $50.00 to $60.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance