Consultant, Manufacturing/Process Validation Engineer, Medical Device
Our client, a Cardiovascular start up, has engaged GForce Life Sciences to provide a manufacturing/process validation engineer. This position will report to a Sr Quality Director. This individual will be responsible for (XYZ). This position requires the ability to do Support the clients transition from clinical stage to commercialization within manufacturing, process, and automation engineering. Evaluate and optimize existing processes, design & implement custom fixtures, tooling, automated equipment within and outside a cleanroom environment. Work closely with the R&D, Operations, and Quality Systems staffs to improve existing processes and perform process validations. This hands-on role requires accountability and the ability to work with minimal supervision.
Duties / Expectations of Role
- Document, assemble, and qualify production assembly / test / inspection fixtures and equipment.
- Specify, procure and implement off the shelf automated and semi-automated equipment
- Implement custom equipment as-needed.
- Create verification or 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. Keep manager informed of changes in work schedule and/or workload.
- Maintain compliance to QSR systems in coordination with the Document Control and Quality Assurance functions.
Mandatory 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
Nice to Have
- Catheter Manufacturing, experience with auto-fusers, hot boxes, UV curing.
- Design Transfer Experience
- Quality Experience – capability analysis, CAPA, MRB, calibration, metrics, etc.
Term & 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