Senior Process Engineer

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

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Minimum Qualifications:

• 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.

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).