Job Title:  Engineer Senior (JP7553)
Location: Thousand Oaks, CA. (MUST BE LOCAL - Onsite Essential – pending lifting of COVID restrictions)
Employment Type:  Contract
Business Unit: Final Product Technologies Quality
Duration: 1+ year (with likely extensions)
Posting Date: 8/17/20
 
 
3 Key Consulting is hiring an Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:
Provide quality oversight with regards to the development of combination products and fulfillment of regulatory commitments. Potential scope of products includes a wide range of devices, such as:

• Needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.

 
The qualified candidate will both lead and/or support technical teams to ensure successful device development and/or fulfillment of regulatory commitments. The role of the Senior Engineer is to provide quality oversight to one or more cross-functional teams to utilize technologies and methodologies that support short-cycle robust device development or accelerated compliance efforts.  Responsibilities include:

• Work cross-functionally with individuals and project teams in Marketing, Operations, and Development.
• Ensure compliance to design controls and fulfillment of user needs during combination product development or design changes, including proper and compliant integration of different subsystems as required.
• Provide quality oversight and guidance regarding the development of process control plans and implementation of process improvements/changes.
• Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods.
• Provide comprehensive quality guidance and advice to counterparts and stakeholders.

 
Why is the Position Open?
Backfill.
 
Top Must-Have Skill Sets:

• Hands on test method qualification and validation experience. (3-5 years of experience).
• Experience working in a cGMP environment for Combination Products or Medical Devices (3-5 years of experience).
• Attention to detail, and ability to communicate to all levels of an organization.(3-5 years of experience).

 
Day to Day Responsibilities:

• Hands on test method qualification and validation experience.
• Experience working in a cGMP environment for Combination Products or Medical Devices.
• Attention to detail, and ability to communicate to all levels of an organization.

 
 
Basic Qualifications:

• BS or BE in Engineering and previous experience in a medical device or pharmaceutical industry.
• 8 years’ current experience with engineering processes/procedures and quality tools.
• Led projects from development through the 510k and PMA approval process.
• Strong background in engineering and commercialization of electro-mechanical medical devices.
• Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA.
• Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
• Experience in drug/device combination product design and development.
• Small scale device assembly and/or benchtop testing experience.
• Experience with Automated Test Equipment (ATE).
• Experience with regard to Measurement Systems Analysis/GRR.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Strong critical thinking, problem solving, risk assessment, and risk management skills.
• Must be capable of working on multiple projects in a deadline driven environment.
• Familiarity with the following standards:
  • Quality System Regulation – 21CFR820.
  • Risk Management – EN/ISO 14971.
  • EU Medical Device requirements – Council Directive 93/42/EEC; Medical Electrical Equipment – EN/ISO 60601

 
Employee Value Proposition:
Great way to gain new perspective on combination products. Helping improve the end to end life cycle products.
 
Red Flags:
Lack of practical experience.
 
Interview process:
Video Skype Panel Interview
 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.