Validation & Verification Engineer, Medical Drug Delivery Device; Hybrid JP

Job Title: Validation & Verification Engineer, Medical Drug Delivery Device (Hybrid) - (JP10785)

Location: Thousand Oaks, CA (Hybrid, once a week or once bi-weekly on site)

Employment Type: Contract to Hire

Business Unit: Auto Touch Drug Delivery Device - Platform Team

Duration: 1+ years with likely extensions or conversion to permanent

Posting Date: 09/07/2022

Note: Consultant needs to be on site 2 - 4 times per month.

3 Key Consulting is hiring a Validation Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description: Scope includes electro-mechanical delivery devices, such as fluid transfer devices, reusable automatic injectors, or micro-infuser delivery pump systems with the embedded firmware and hardware. 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, device verification activities such as revising product requirement specifications, supporting new development project teams, analytical failure analysis and implementing design solutions, authoring verification protocols and compiling verification report and getting them ready for approval.

Responsibilities:

• 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.
• Participate in system-level and subsystem-level root cause investigation from firmware and electrical perspective, coordinate design improvements with development partners, tactical planning, and execution of design changes and improvements.
• Support Product Delivery Teams (PDT), including creating and/or reviewing quality documents, participating in CAPA implementation, and generating or supporting Engineering Change Request (ECR) & Engineering Change Order (ECO) activities.
• Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.

Basic Qualifications:

Doctorate Degree, or Master’s Degree and 2 years of Engineering and/or Operations experience within a cGMP manufacturing environment or biotech/medical device manufacturing environment, or Bachelor’s Degree and 4 years of Engineering and/or Operations experience within a cGMP manufacturing environment or biotech/medical device manufacturing environment.

Preferred Qualifications:

• Master’s degree in biomedical/electrical/computer science or related Engineering field and 4+ years of related engineering experience
• Background in development and commercialization of class II or class III electromechanical medical devices, especially drug delivery devices, syringe and vial fill process
• Systems Engineering design experience and thinking, driving user needs to design requirements to verified and validated final product outputs through design requirement management systems
• Strong understanding of design controls, life cycle management through design change control, failure investigation and root cause analysis
• Familiar with standards and regulations:
  Quality System Regulation – 21
  
  CFR
  820, ISO 14971, EU Medical Device requirements – Council Directive 93/42/EEC, ISO 11608-1/11608-4/11608-5/ISO 23908, ISO 10993
• Familiar with electrical schematic design and layout, and embedded software coding structure and workflow
• Understanding of Medical Device software and hardware design requirements
• Understanding of ISO 62304 and FDA software validation requirements
• Ability to work independently and across functional teams
• Excellent (technical) written and verbal communication

Top Must-Have Skill Sets:

• Willing to look at new grads; ideal candidate 2+ years, BS or MS in engineering, biochemistry, biomedical, chemistry
• Knowledge or experience of IEC
  60601, ISO
  13485, ISO 14791 or FDA Title 21 CFR 820 (preferred)
• Software and/or hardware background

Red Flags:
No BS degree
No engineering or science background, nonrelated experience

Interview process: Phone screen, then panel video interview. We invite qualified candidates to send resume to the recruiting contact. If you are not interested in pursuing this position, please review other positions on the company’s careers site. You are also welcome to share this opportunity with anyone who might be interested.