Process Engineer, LP-MIM
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Job Location:
Mahwah, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
Process Engineer (Defined Contract Term) Advanced Operations LPMIM
Location: Mahwah NJ
Department: Advanced Operations & Manufacturing
Employment Type: Defined Term 28 months On-site
About the Role
Were looking for an entrylevel Process Engineer to support LPMIM (Low-Pressure Metal Injection Molding) manufacturing processes within Advanced Operations. Youll 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 LPMIM endtoend while collaborating across Advanced Technology Manufacturing and Quality.
Key Responsibilities
Process Ownership & Improvement
- Support LPMIM 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 firstpass 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 SMEs 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 LPMIM 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:
- Bachelors degree in Mechanical Materials Chemical Manufacturing or Industrial Engineering (or related).
- 02 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.
Required Experience:
IC
Key Skills
- Lean Manufacturing
- Six Sigma
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Process Engineering
- cGMP
- Kaizen
- Programmable Logic Controllers
- Manufacturing
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
