Career Category

Job Description

Electromechanical Device Engineer, Combination Product Operation

Job Details:

The device engineer will participate in design development and lifecycle management-related activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, developing test procedures, scale-up, global launch, supplier development, and continuous improvement.

Scope includes mechanical and electro-mechanical delivery devices, such as fluid transfer devices, reusable automatic injectors, or micro-infuser delivery pump systems. The qualified candidate will be part of a sustaining device engineering team that ensures the design history files of these systems are maintained. The engineer will participate in multi-functional teams, leading device design activities such as developing product improvements, supporting new development project teams, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow-through of commitments.

Responsibilities:

• Apply all conventional aspects of the subject matter, functional area, and their assignments; plans and conducts work requiring judgment in the independent evaluation, selection, and meaningful adaptation and modification of standard engineering techniques, procedures, and criteria and devises new approaches to problems encountered.
• Accountable for maintaining technical records within design history files associated with assigned products.
• Support system-level design, development, and V&V work for commercial lifecycle management changes or in support of new project development.
• Develop test methods, generate, and maintain design specifications, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
• Lead system-level root cause investigation, coordinate design improvements with development partners, tactical planning, and execution of design changes and improvements.
• Supports Product Delivery Teams (PDT), including creating and or reviewing quality documents, participating in Corrective And Preventive Action (CAPA) implementation, and generating or supporting ECR (Engineering Change Request) & ECO (Engineering Change Order) activities.
• Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
• Performs as an individual contributor with leadership attributes to optimally represent device engineering within a large network/matrix organization

Basic Qualifications:

• Master’s degree OR
• Bachelor’s degree and 2 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment OR 
• Associate’s degree and 6 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment OR  
• High school diploma / GED and 8 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment 
• Up to 10% domestic and international travel is required
• The position is in Thousand Oaks, CA.

Preferred Qualifications:

• Master’s or Bachelor’s degree in biomedical or mechanical Engineering field and 3+ years of related engineering experience.
• familiarity with 3D CAD modeling using Solidworks.
• familiarity with plastic injection molding design and engineering.
• A background in the development and commercialization of class II or class III medical devices.
• Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion.
• Familiar with the following standards and regulations:
  • Quality System Regulation – 21CFR820,
  • Risk Management – ISO 14971,
  • EU Medical Device requirements – Council Directive 93/42/EEC
• Ability to work independently and across functional teams.
• Excellent (technical) written and verbal communication