Job Details

Job Title: Engineer Senior, Biotech Combination Products - Hybrid (JP13709)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Prefilled Syringes - New Product Development
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $44 - $48/hour W2 with benefits
Posting Date: 2/11/2025.
Notes: Onsite Thousand Oaks, CA - 2-3 days per week onsite

3 Key Consulting is hiring! We are recruiting an Engineer Senior, Biotech Combination Products for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
B.S. and a minimum of 3+ strong years of experience. 5 YOE is ideal.
Experience working on prefilled syringes or vials. Combination product experience. Regulatory experience.

The Device Engineer will participate in the medical device/combination product design, development, and commercialization activities for drug delivery devices, focusing on prefilled syringes.

Key responsibilities include:

• Leading test procedure development and functional test execution
• Leading material inventory management for prefilled syringe programs, including material forecasting and material custody across multiple sites and functional groups.
• Authoring technical plans and reports
• Performing advanced statistical data analysis
• Supporting Leading technical assessments and root cause investigations as well as planning and delegation of sub-tasks to other team members.
• Transfer of information to manufacturing sites, engagement with suppliers
• Maintenance of Design History File content consistent with Good Documentation Practices
• Training junior staff on physical test methods, sample preparation protocols and procedures, and effective report writing.
• Reviewing primary data collected from peers in support for various design controls activities, including characterization and design verification.
• Supporting design transfer activities by leading cross-functional coordination of sample procurement and testing.
• Supporting the setting of specification limits for platform devices through human factors studies benchtop testing.

Essential Skills:

• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
• Plans and conducts work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques/procedures/criteria, and devises new approaches to encountered challenges.
• Generates and maintains design specifications, protocol and report writing, prototyping, design of experiments/statistical process control product optimization, design verification & validation, FMEA, etc.
• System level root cause investigation; CAD/SolidWorks proficiency; tolerance analysis; capability analysis.
• Coordinate and implement design improvements with development partners.
• Collaborate with scientists and engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
• Accountability of maintaining technical records within product design history files.
• Individual contributor with leadership attributes to effectively represent device engineering within a large network/matrix organization.
• Working proficiency and familiarity with governing standards and regulations, including Quality System Regulation (21CFR820) and Risk Management (ISO 14971).

Preferred Qualifications:

• Degree in the field of Mechanical or Biomedical Engineering, or related field
• Medical device industry and/or regulated work environment experience
• Excellent written and verbal communication skill
• Understanding and experience in:
• Development/commercialization of medical devices and knowledge of manufacturing processes
• Initiating and bringing complex projects to conclusion
• Ability to work independently and dynamic cross functional teams
• Design controls
• Failure investigation
• Applied statistics

Top Must Have Skill Sets:

• Pharma background.
• Physical testing experience
• Design controls experience

Red Flags:
Poor communication skills
Lack of hands on testing experience

Why is the Position Open?
Supplement to current team

Interview Process:
One rounds of interviews

We invite qualified candidates to send your resume to ...@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.

Regards,

3KC Talent Acquisition Team