Engineer Senior, Biotech Combination Products - Hybrid (JP13709)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
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. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Santa Ana , Engineer Senior, Biotech Combination Products - Hybrid (JP13709), Engineering , Thousand Oaks, California
