Validation Verification Engineer Medical Drug Delivery Device Hybrid - JP10785
Validation Verification Engineer Medical Drug Delivery Device Hybrid - JP10785
Posted on :
10-04-2025
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Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
10-04-2025
Job Description
Job Title:Validation & Verification Engineer Medical Drug Delivery Device (Hybrid) (JP10785
Location:Thousand Oaks CA (Hybrid once a week or once biweekly on site)
Employment Type: Contract to Hire
Business Unit:AutoTouch Drug Delivery Device Platform Team
Duration:1 years with likely extensions or conversion to permanent
Posting Date:09/07/2022.
Note: Consultant needs to be on site 2 4 times per month.
3 Key Consulting is hiring aValidation Engineerfor a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
Scope includes electromechanical delivery devices such as fluid transfer devices reusable automatic injectors or microinfuser delivery pump systems with the embedded firmware and hardware. The qualified candidate will be part of a sustaining device engineering team that ensures the design history files of these systems are maintained. The engineer will participate in multifunctional teams device verification activities such as revising product requirement specifications supporting new development project teams analytical failure analysis and implementing design solutions authoring verification protocols and compiling verification report and getting them ready for approval.
Responsibilities:
Doctorate Degree orMasters Degree and 2 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment orBachelors Degree and 4 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment.
Preferred Qualifications:
Top MustHave Skill Sets:
Red Flags:
No BS degree
No engineering or science background nonrelated experience
Interview process:
Phone screen then panel video interview.
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
Location:Thousand Oaks CA (Hybrid once a week or once biweekly on site)
Employment Type: Contract to Hire
Business Unit:AutoTouch Drug Delivery Device Platform Team
Duration:1 years with likely extensions or conversion to permanent
Posting Date:09/07/2022.
Note: Consultant needs to be on site 2 4 times per month.
3 Key Consulting is hiring aValidation Engineerfor a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
Scope includes electromechanical delivery devices such as fluid transfer devices reusable automatic injectors or microinfuser delivery pump systems with the embedded firmware and hardware. The qualified candidate will be part of a sustaining device engineering team that ensures the design history files of these systems are maintained. The engineer will participate in multifunctional teams device verification activities such as revising product requirement specifications supporting new development project teams analytical failure analysis and implementing design solutions authoring verification protocols and compiling verification report and getting them ready for approval.
Responsibilities:
- Accountable for maintaining technical records within design history files associated with assigned products.
- Support systemlevel design development and V&V work for commercial lifecycle management changes or in support of new project development.
- Develop test methods generate and maintain design specifications protocol & report writing prototyping DOE/SPC product optimization design verification & validation FMEA etc.
- Participate systemlevel and subsystemlevel root cause investigation from firmware and electrical perspective coordinate design improvements with development partners tactical planning and of design changes and improvements.
- Supports Product Delivery Teams (PDT) including creating and or reviewing quality documents participating in Corrective And Preventive Action (CAPA) implementation and generating or supporting ECR (Engineering Change Request) & ECO (Engineering Change Order) activities.
- Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
Doctorate Degree orMasters Degree and 2 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment orBachelors Degree and 4 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment.
Preferred Qualifications:
- Masters degree in biomedical/electrical/computer science or related Engineering field and 4 years of related engineering experience
- A background in the development and commercialization of class II or class III electromechanical medical devices especially drug delivery devices syringe and vial fill process
- Systems Engineering design experience and thinking driving user needs to design requirements to verified and validated final product outputs through design requirement management system such as DOORs RequisitePro Quality Center or equivalent.
- Strong understanding and experience in design controls life cycle management through design change control process failure investigation and root cause analysis initiating and bringing complex projects to conclusion
- Familiar with the following standards and regulations: Quality System Regulation 21CFR820 Risk Management ISO 14971 EU Medical Device requirements Council Directive 93/42/EEC Drug delivery device and needle standard ISO 116081/ISO 116084/ISO 116085/ISO23908 and biocompatibility standard ISO 10993
- Familiar with electrical schematic design and layout and embedded software coding structure and workflow
- Understanding of Medical Device software and hardware design requirements.
- Understanding of ISO 62304 and FDA software validation requirements
- Ability to work independently and across functional teams.
- Excellent (technical) written and verbal communication
Top MustHave Skill Sets:
- Willing to look at new grads ideal candidate 2 years
BS or MS degree in engineering biochemistry biomedical chemistry - Knowledge or experience of IEC60601 ISO13485 ISO 14791 or FDA Title 21 CFR 820 (preferred)
- Software and/or hardware background
Red Flags:
No BS degree
No engineering or science background nonrelated experience
Interview process:
Phone screen then panel video interview.
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Employment Type
Full Time
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