29 Engineer, Biopharma Medical Device (JP10473) Jobs in Thousand Oaks, CA
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Engineer, Biopharma Medical Device (JP10473)
$98k-119k (estimate)
Full Time | Business Services
5 Months Ago
3 Key Consulting is Hiring an Engineer, Biopharma Medical Device (JP10473) Near Thousand Oaks, CA
Job Title: Engineer, Biopharma Medical Device (JP10473)Location: Thousand Oaks, CA. (Hybrid, 50% onsite/remote)Employment Type: ContractBusiness Unit: PFS And Lyo Kit Platforms
Duration: 1year with likely extensions or conversion to permPosting Date: 06/23/20223 Key Consulting is hiring an Engineer, Medical Drug Delivery Device for a consulting engagement with our direct client, a leading global biopharmaceutical company.Job Description:The Device Engineer will participate in the design development and lifecycle management related design center activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, develop test procedures, scale-up and global launch, supplier development, and continues improvement.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 and electro-mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as developing product enhancements, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.Essential skills and Responsibilities:
BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology with 3 years of experience within the pharmaceutical/biotechnology industry.Preferred Qualifications:
Supplement additional workload on team.Top Must-Have Skill Sets:
To work for a dynamic teamInterview process:Webex with HMPanel interviewWe invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
Duration: 1year with likely extensions or conversion to permPosting Date: 06/23/20223 Key Consulting is hiring an Engineer, Medical Drug Delivery Device for a consulting engagement with our direct client, a leading global biopharmaceutical company.Job Description:The Device Engineer will participate in the design development and lifecycle management related design center activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, develop test procedures, scale-up and global launch, supplier development, and continues improvement.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 and electro-mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as developing product enhancements, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.Essential skills and Responsibilities:
- 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.
- Accountability of maintaining technical records within design history file associated with assigned products
- Develop Test Method, generate and maintain design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
- Lead system level root cause investigation, coordinate design improvements with development partners, strategic planning and execution of design changes and improvements.
- Works with Scientists and Engineers internally and externally 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 regulation:=
- Quality System Regulation – 21CFR820
- Risk Management – ISO 14971
- EU Medical Device requirements – Council Directive 93/42/EEC
BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology with 3 years of experience within the pharmaceutical/biotechnology industry.Preferred Qualifications:
- Degree in the field of Mechanical or Biomedical
- Medical device industry experience and regulated work environment experience
- Background in developing and commercialization of medical devices and knowledge of manufacturing processes
- Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion and the ability to work independently and dynamic cross functional teams
- Excellent written and verbal communication skill
Supplement additional workload on team.Top Must-Have Skill Sets:
- Must have hands on Laboratory experience in a GLP Setting (Science or Engineering Lab)
- BS Degree in the field of Mechanical, Chemistry, Biomedical, Engineering, or any science degree
- Seeking a candidate with regulated work environment experience
To work for a dynamic teamInterview process:Webex with HMPanel interviewWe invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$98k-119k (estimate)
POST DATE
12/13/2023
EXPIRATION DATE
06/02/2024
WEBSITE
3keyconsulting.com
HEADQUARTERS
WEST HILLS, CA
SIZE
100 - 200
FOUNDED
2009
TYPE
Private
REVENUE
$50M - $200M
INDUSTRY
Business Services
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