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

• 2+ 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).