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Engineer, Medical Devices (JP12014)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Engineer, Medical Devices (JP12014)
Location: Thousand Oaks, CA. 91320
Business Unit: PFS And Lyo Kit Platforms
Employment Type: Contract
Duration: 1+ years with possible extensions or conversion to FTE
Rate: $37 - $41/hour W2
Posting Date: 11/29/2023
Notes: ONSITE - candidate is expected to be in mechanical lab and support.
3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Ideal Candidate: Force testing, good documentation and lab safety, technical writing, electronic data, Data verification i.e. what goes into reviewing technical documentation. Familiarity with Minitab and JMP. basic statistics, ANOVA and capability experience. Bachelor Degree and 2 years of experience. working in a mechanical lab. Familiarity with combination product development. Familiarity with design controls. specifically prefilled syringes.
Job Description:
The Device Engineer will participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.
Scope includes mechanical delivery devices, such as Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, and defend inspection and ensure the follow through of commitments.
Essential skills and Responsibilities:
Master degree
OR Bachelor degree and 2 years of experience
OR Associate degree and 6 years of experience
Preferred Qualifications:
Day to Day Responsibilities:
Employee Value Proposition: great opportunity for growth in career
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
2-3 rounds of interviews.
Individual Interviews (x2) - WebEx or In-person
Panel Interview (x1) – WebEx
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.
Location: Thousand Oaks, CA. 91320
Business Unit: PFS And Lyo Kit Platforms
Employment Type: Contract
Duration: 1+ years with possible extensions or conversion to FTE
Rate: $37 - $41/hour W2
Posting Date: 11/29/2023
Notes: ONSITE - candidate is expected to be in mechanical lab and support.
3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Ideal Candidate: Force testing, good documentation and lab safety, technical writing, electronic data, Data verification i.e. what goes into reviewing technical documentation. Familiarity with Minitab and JMP. basic statistics, ANOVA and capability experience. Bachelor Degree and 2 years of experience. working in a mechanical lab. Familiarity with combination product development. Familiarity with design controls. specifically prefilled syringes.
Job Description:
The Device Engineer will participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.
Scope includes mechanical delivery devices, such as Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, and defend inspection and ensure the follow through of commitments.
Essential skills and Responsibilities:
- Adheres to strict documentation practices in a GMP regulated environment
- Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
- Authors and reviews technical documentation including protocols, reports, and technical assessments
- Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
- Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
- Maintains combination product design history files for assigned products
- Develops characterization test methods through fixture prototyping, reference sample creation, and GR&R analysis
- Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
- Provide general laboratory support including inventory management, sample shipments, and cleanup.
- Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications
- Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization
- At a minimum familiar with the following standards and regulations:
- Quality System Regulation – 21CFR820
- Risk Management – ISO 14971
- EU Medical Device requirements – Council Directive 93/42/EEC
Master degree
OR Bachelor degree and 2 years of experience
OR Associate degree and 6 years of experience
Preferred Qualifications:
- Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
- Minimum 1 year of scientific or engineering experience in a GxP regulated environment
- Statistical Analysis software (Minitab or JMP)
- Strong technical writing skills
- CAD fixturing software (SolidWorks)
- Instron force tester using BlueHill Universal
- Experience with design controls; including (but not limited to) verification and design transfer
- Understanding of risk assessments including hazard and probability analysis
- Background in medical device development, commercialization, and knowledge of manufacturing processes (fill-finish)
- Ability to work independently and dynamically across functional team
- Excellent written and verbal communication skills
- Ability to support complex workstreams under demanding timelines.
- Hands on Laboratory Experience in a GxP Setting (Science or Engineering Lab)
- Good Communication and Technical Writing Skills
- Data Analysis and Problem Solving
Day to Day Responsibilities:
- The device engineer will support a senior engineer on a variety of projects related to laboratory testing, life cycle management, and product-based initiatives regarding prefilled syringes in both the commercial and developmental space.
- The engineer will be expected to author protocols, reports, and further technical documentation while adhering to GMP standards. Laboratory testing will primarily include the use of an Instron force tester and vision systems.
- The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material.
- Fill-Finish experience is a bonus but not mandatory.
- The engineer will be evaluated on ability to complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality.
Employee Value Proposition: great opportunity for growth in career
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
- No previous industry or laboratory experience
- Unfamiliar with Good Documentation Practices
2-3 rounds of interviews.
Individual Interviews (x2) - WebEx or In-person
Panel Interview (x1) – WebEx
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