Medical Device Engineer Job at Planet Pharma, Thousand Oaks, CA

cUdaSzg4bEdOWHJ1eEcyT0ppVmVSVGNm
  • Planet Pharma
  • Thousand Oaks, CA

Job Description

617633

Our client, a leading Biotechnology company located in Thousand Oaks, CA, is looking for a Medical Device Engineer to participate in the design, development, and lifecycle management of 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.

Required Skills:

  • Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
  • Understanding of Mechanical Design Engineering Concepts
  • Experience with Final Drug Product and/or Drug Product, medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
  • Experience with design controls; including (but not limited to) design verification and transfer
  • Understanding of risk assessments including hazard and probability analysis
  • Experience with investigations and quality records
  • Laboratory and electronic lab notebook experience
  • Statistical Analysis software (Minitab or JMP)

Responsibilities:

  • Adheres to strict documentation practices in a GMP regulated environment
  • Engineering competency in all conventional aspects of the subject matter, functional area, and assignments
  • Plans and performs work, independently evaluating, selecting, and adapting standard methods, and creating new solutions to engineering problems.
  • Authors and reviews technical documentation including protocols, reports, and technical assessments
  • Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
  • Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
  • Maintains device and combination product design history files for assigned products
  • Ensure test methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errors
  • 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

***Compensation within this range will be commensurate with level of experience***

Job Tags

Similar Jobs

Trigyn Technologies

Customer Service / Call Center Representative (Phone Support Experience) Job at Trigyn Technologies

 ...Immediate contract opportunity for Customer Service/Call Center Executive with direct client in Long Island City, NY. Trigyn's Direct Government Client has openings for Call Center / Customer Service Executive, who can work onsite in Long Island City, NY. PLEASE NOTE:... 

Adelphi Staffing

Interventional Radiologist Job at Adelphi Staffing

 ...JOB OVERVIEW Job Title: Interventional Radiologist Job Type: Locum Tenens Location: Manteca, CA Service Setting: Outpatient Clinic Coverage Type: Clinical Only Coverage Period: 01/02/2026 Ongoing (future dates available) Clinical Shift Schedule... 

Hope Center

Director of Nursing (DON) Job at Hope Center

 ...Job Description Hope Center is hiring a Director of Nursing (DON) in Bronx, NY. DUTIES: Supervises all nursing staff in...  ...nursing facilities, where residents find their physical, social and spiritual needs met by caring, compassionate people. Hope Center is a... 

Medpace

Clinical Data Coordinator - Entry Level - Chemistry Degree Job at Medpace

 ...we are currently seeking a full-time, office-based Clinical Data Coordinator to join our Data Management team. This position involves working on a team to accomplish...  ...s T&D members Responsibilities Validate entry database designs Report metrics and data trends... 

Ochsner LSU Health

Pulmonary/Critical Care Physician Job at Ochsner LSU Health

 ...Ochsner LSU Health System-Monroe Medical CenterandLSU Health Sciences Center-Shreveport seeks a Pulmonary/Critical Care physician to join a thriving faculty. This position is for an Assistant or Associate Professor position in the Division of Pulmonary & Critical...