Manufacturing Process Validation Engineer
2 days ago
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.
- 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.
- Catheter Manufacturing, experience with auto-fusers, hot boxes, UV curing.
- Design Transfer Experience.
- Quality Experience - capability analysis, CAPA, MRB, calibration, metrics, etc.
- 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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