Senior Process Engineer

Stryker•Mahwah, NJ

1d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Mechanical Engineering
4+ years in mechanical, process, or manufacturing engineering.
Hands-on experience in high-volume manufacturing environments, preferably medical devices.
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).

Nice To Haves

Metal injection molding, mold design, or investment casting.

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.
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.
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