Manufacturing Process Validation Engineer

2 days ago

Santa Clara, California, United States GForce Life Sciences Full time
Job Title: Manufacturing Process Validation Engineer

GForce Life Sciences is seeking a highly skilled Manufacturing Process Validation Engineer to join our team. As a key member of our engineering team, you will be responsible for ensuring the quality and reliability of our medical devices.

Key Responsibilities:
  • Design and implement custom fixtures, tooling, and automated equipment to support manufacturing and process validation.
  • Evaluate and optimize existing processes to improve efficiency and quality.
  • Work closely with R&D, Operations, and Quality Systems staff to improve existing processes and perform process validations.
  • Develop and implement verification and validation protocols, execute studies and/or tests, and author and release subject reports.
  • Assist in characterization studies and Design of Experiments (DoE).
  • Author and perform validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
  • Write and maintain manufacturing documentation, including material and component specifications, work instructions, BOMs, routers, Process FMEAs, DMR, protocols, reports, and DHF documents.
  • Maintain compliance with Ancora Heart's quality systems, including all applicable SOPs, non-conforming materials disposition, corrective action investigations and closure, and Engineering Change Order (ECO).
  • Train operators on new processes, tools, and equipment.
  • Work as the liaison among R&D, Operations, and Quality Systems to ensure a smooth transition of design changes, tooling, and fixturing.
  • Assure product and process quality by designing testing methods; testing sub-assemblies, finished product, and process capabilities.
  • Develop, qualify, and implement processes to improve manufacturability.
  • Complete projects and tasks in a timely manner consistent with corporate objectives.
Requirements:
  • Minimum B.S. in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or similar Engineering discipline.
  • 5-9+ years of related experience.
  • Knowledge of FDA, QSR, and MDR regulations and relevant FDA Guidance and ISO standards.
  • Background in IQ/OQ/PQ.
  • Process Validation - Experience with MVP (Master Validation Plans).
  • Knowledge and experience with Packaging (pouch sealing).
  • Experience with facility layout optimization.
  • Experience with Test Method Validation and/or Gage R&R.
  • SPC.
  • Ability to work in a CER ISO 7 environment, engage with medical device assemblers to learn and understand current manufacturing challenges.
  • Background in DFMEA, Process Flowcharting, test methods, quality inspection methodology, report writing.
  • Experience in the development, design, and execution of process validation protocols.
  • Solid protocol and writing skills.
  • Experienced with Mini-Tab and SolidWorks.
Preferred Qualifications:
  • Catheter Manufacturing, experience with auto-fusers, hot boxes, UV curing.
  • Design Transfer Experience.
  • Quality Experience - capability analysis, CAPA, MRB, calibration, metrics, etc.
Term and Start:
  • 9 months+.
  • ASAP.
  • Full time (40 hours/week).
  • Possibility of extension or perm.
  • Onsite 5 days a week in Santa Clara.
  • Benefits included (Medical, Dental, Vision, 401k).
  • Pay range - $60-70/hr.

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