Apply to Engineer Senior, Biotech Combination Products - Hybrid (JP13709)

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 recruiting@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.