Manufacturing Engineer II

Confluent Medical Technologies INC; Fremont (CA); On-site; USD 87,000 - 146,000; Full time

Job summary

Confluent Medical Technologies is seeking a Manufacturing Engineer II to support and optimize manufacturing processes for Nitinol materials. You will troubleshoot process issues, drive continuous improvement, and partner across functions to ensure high-quality, efficient production.

The role emphasizes process validation, documentation, and collaboration with Quality, R&D, and Operations to achieve cost efficiency and scalable manufacturing outcomes.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related field.
• 2–5 years of manufacturing engineering experience.
• Experience in a regulated manufacturing environment preferred (medical device, aerospace, or similar).
• Experience with metals processing; Nitinol or specialty alloys strongly preferred.

Responsibilities

• Provide daily engineering support for material processing operations and troubleshoot issues to minimize downtime and scrap.
• Lead and support continuous improvement initiatives using Lean and Six Sigma methodologies.
• Support transfer and scale-up of new Nitinol materials and processes into production and perform process validation activities.
• Ensure adherence to FDA, ISO 13485, and internal quality system requirements; support CAPAs.
• Collaborate with Operations, Quality, R&D, and Supply Chain to guide operators and junior engineers.

Skills

Lean Six Sigma

Statistical analysis

Minitab

Cross-functional collaboration

Education

Bachelor’s in Mechanical Engineering

Bachelor’s in Materials Science

Bachelor’s in Metallurgical Engineering

Tools

Minitab

GD&T

Job description

Salary Range:$87,400.00 - $145,600.00Job Description:Confluent Medical Technologies is a financially healthy and rapidly growing medical device company whose employees are passionate about providing life-saving solutions to our customers through a collaborative and high-impact work environment. Our moderate size, diversity of technologies, and broad material science capabilities provide an environment in which our employees can develop broad skill sets and directly influence product development and manufacturing outcomes.The Manufacturing Engineer, II is a junior level individual contributor responsible for supporting and optimizing manufacturing processes within the Nitinol Materials operations. This role provides hands-on engineering support, drives continuous improvement initiatives, and partners cross-functionally to ensure high-quality, efficient production of Nitinol materials. The role operates on moderately complex problems and contributes to process scalability, cost efficiency, and product quality.ResponsibilitiesManufacturing Engineering Support:Provide daily engineering support for material processing operationsTroubleshoot process, material, and equipment issues to minimize downtime and scrapDevelop, update, and maintain manufacturing documentation including work instructions, MOM/BOM configuration and process specificationsMonitor and analyze process performance and implement improvementsProcess Improvement:Lead and support continuous improvement initiatives using Lean and Six Sigma methodologiesImprove process capability (Cp/Cpk), yield, and throughputIdentify and implement cost reduction opportunities through process optimization and material utilizationNew Product & Process Introduction:Support transfer and scale-up of new Nitinol materials and processes into productionAssist with process development, manufacturability assessments, and production readinessExecute process validation activities (IQ/OQ/PQ) and ensure compliance with internal requirementsQuality & Compliance:Ensure adherence to FDA, ISO 13485, and internal quality system requirementsSupport nonconformance investigations, root cause analysis, and corrective/preventive actions (CAPA)Partner with Quality to define process controls and inspection requirementsCollaboration & Technical Contribution:Partner cross-functionally with Operations, Quality, R&D, and Supply ChainProvide technical guidance to operators, technicians, and junior engineersContribute to a culture of safety, accountability, and continuous improvementQualificationsEducation & Experience:Bachelor’s degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related field2-5 years of manufacturing engineering experience.Experience in a regulated manufacturing environment (medical device, aerospace, or similar) preferredExperience with metals processing; Nitinol or specialty alloys strongly preferredKnowledge of manufacturing processes such as tube conversion, strip processing, annealing, wire EDM, centerless grinding preferred.Experience with statistical analysis and data-driven problem solving (e.g., Minitab)Familiarity with process validation (IQ/OQ/PQ)Ability to interpret engineering drawings and GD&TCore Competencies:Strong analytical and problem-solving skillsAbility to work independently with sound technical judgmentEffective communication and cross-functional collaborationHigh attention to detail with a focus on quality and complianceContinuous improvement mindsetAdditional InformationWork Environment: Manufacturing floor and office environment supporting Nitinol materials production