Job details
Process Engineer (Defined Contract Term)– Advanced Operations, LP‑MIM
Location: Mahwah, NJ
Department: Advanced Operations & Manufacturing
Employment Type: Defined Term – 28 months, On-site
About the Role
We’re looking for an entry‑level Process Engineer to support LP‑MIM (Low-Pressure Metal Injection Molding) manufacturing processes within Advanced Operations. You’ll help scale and stabilize production, drive process improvements, and ensure compliance with medical device quality systems. This role is ideal for technically curious engineers eager to learn LP‑MIM end‑to‑end while collaborating across Advanced Technology, Manufacturing, and Quality.
Key Responsibilities
Process Ownership & Improvement
- Support LP‑MIM production lines across upstream and downstream operations: feedstock handling, molding parameters, debinding and sintering cycles, dimensional & visual control, CNC machining, blasting, robotic belting/polishing, surface finishing, and Metrology.
- Execute continuous improvement projects using Lean/Six Sigma tools (DMAIC, 5S, Kaizen) to reduce scrap, cycle time, and cost.
- Build, maintain, and improve Control Plans, PFMEA, Work Instructions, and Standard Operating Procedures (SOPs).
Validation & Compliance
- Author and execute IQ/OQ/PQ protocols for equipment and process validation in alignment with ISO 13485 and FDA 21 CFR 820 requirements.
- Collect/analyze validation data and author technical reports with defensible statistical methods (e.g., capability studies, Gage R&R).
Data & Quality Analytics
- Monitor process capability (Cp/Cpk), SPC charts, yield and first‑pass quality; identify trends and root causes; implement corrective/preventive actions.
- Support measurement system analysis, dimensional inspection plans, and GD&T compliance.
Technical Support
- Partner with SME's on troubleshooting activities (press setup, binder burnout anomalies, furnace profiles, part distortion/porosity).
- Recommend parameter windows and robustness studies (DOE) for LP-MIM and machining operations.
- Collaborate with suppliers on manufacturing equipment, tooling, and assist with incoming inspection criteria.
New Product Introduction & Design Transfer
- Participate in NPI projects to bring new LP‑MIM components from concept to production readiness.
- Support Design Transfer activities by translating design requirements into robust manufacturing processes and documentation.
- Develop and validate new tooling, fixtures, and process parameters for new products.
- Collaborate with R&D and Design Engineering to ensure manufacturability, cost targets, and quality standards are met.
- Execute risk assessments and contribute to DFM/I (Design for Manufacturability/Inspection) reviews.
- Ensure timely completion of deliverables for Stage-Gate or equivalent product development processes.
Documentation & Training
- Create clear, accurate procedures, visual aids, and line training materials.
- Contribute to risk management and design-transfer activities for new/changed products.
Minimum Requirements:
- Bachelor’s degree in Mechanical, Materials, Chemical, Manufacturing, or Industrial Engineering (or related).
- 0–2 years of experience (internships/co-ops welcome) in manufacturing or process engineering.
Preferred:
- Exposure to medical device manufacturing, ISO 13485, FDA QSR (21 CFR 820), and GMP.
- Experience with PFMEA, Control Plans, and validation (IQ/OQ/PQ) documentation.
- Basic CAD view/markup capability (e.g., SolidWorks/Creo viewer), and familiarity with MES/ERP systems.
- Foundational knowledge of:
- Metal Injection Molding (MIM) or powder metallurgy fundamentals (particle size, binder systems, green part handling).
- Thermal processing (debinding/sintering), furnace profiles, and atmosphere control.
- Statistical tools: SPC, capability analysis (Cp/Cpk), Gage R&R, basic DOE.
- GD&T, tolerance stack-ups, and dimensional metrology.
- Proficiency with Excel and statistical software (e.g., Minitab or equivalent).
- Strong communication, problem-solving, and teamwork skills; ability to work on the production floor.
