Senior Process Engineer
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Job Location:
Mahwah, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
What we want:
The MIM Engineer will lead technical efforts to introduce new medical device products using Metal Injection Molding (MIM) technology and ensure successful scale-up for high-volume production. This role combines strong mechanical engineering expertise with deep knowledge of mold design metal injection molding and hands-on manufacturing experience. The engineer will partner across multiple manufacturing sites and with cross-functional teams to deliver robust compliant and cost-effective processes that meet stringent medical device standards and high-volume output requirements.
Key Responsibilities:
- Collaborate with R&D and Design Engineering to evaluate MIM feasibility for new products.
- Drive Design for Manufacturability (DFM) and Design for Assembly (DFA) reviews for MIM components.
- Develop and optimize MIM processes for scalability and efficiency in high-volume production environments.
- Implement automation strategies and cycle time reduction initiatives to meet production targets.
- Troubleshoot manufacturing issues and implement corrective actions during ramp-up and steady-state production.
- Process Development & Validation:
- Execute IQ/OQ/PQ validation protocols to ensure compliance with FDA and ISO 13485 standards.
- Establish robust process controls and capability studies for high-volume production.
- Lead mold design activities for new product components ensuring precision durability and repeatability for high-volume runs.
- Collaborate with suppliers on tooling fabrication qualification and preventive maintenance programs.
- Partner with Advanced Technology Manufacturing Quality and Supply Chain teams for seamless technology transfer.
- Provide technical support during pilot builds scale-up and continuous improvement initiatives.
- Risk Management & Documentation:
- Conduct PFMEA and implement mitigation strategies for high-volume production risks.
- Maintain DHF and DMR documentation for regulatory compliance.
- Drive Lean and Six Sigma initiatives to reduce scrap improve yield and optimize cycle times.
- Drive design transfer and design review activities required for new product launches
Minimum Qualifications:
- Bachelors degree in Mechanical Engineering
- 4 years in mechanical process or manufacturing engineering.
- Hands-on experience in high-volume manufacturing environments preferably medical devices.
Preferred Certifications:
- Metal injection molding mold design or investment casting.
- Expertise in MIM processes and tooling design for high-volume production
- GD&T Six Sigma Green Belt or ASME standards knowledge.
- Proven track record in NPI and technology transfer in a regulated industry.
- Proficiency in CAD software (SolidWorks Creo)
- Familiarity with validation protocols and regulatory compliance (FDA ISO 13485).
Required Experience:
Senior IC
Key Skills
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Tooling
- Statistical Software
- Process Engineering
- cGMP
- Programmable Logic Controllers
- Public Speaking
- 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
