Senior Manufacturing Engineer

Position Overview

We are seeking a Principal Manufacturing Engineer to serve as our primary Subject Matter Expert (SME) for pressure decay leak test systems and electro-mechanical testing. In this role, you will lead the design, validation, optimization, and continuous improvement of manufacturing processes and test equipment across our production lines.

As a technical authority, you will work with high autonomy to drive complex projects, advance technology implementation, and mentor junior engineers, all while collaborating closely with cross-functional teams in R&D, Quality, Regulatory, and external Contract Manufacturers.

Key Responsibilities

Leak & Test System Engineering (SME)

• Serve as the primary subject matter expert for the design, implementation, validation, and optimization of pressure decay leak test systems across manufacturing lines.
• Define test specifications, parameters, and acceptance criteria in collaboration with R&D, Quality, and Regulatory teams.
• Lead equipment qualification and validation activities (IQ/OQ/PQ) in compliance with FDA and ISO regulations.
• Develop and execute test method validation studies, including Measurement System Analysis (MSA) and Gauge R&R studies.
• Troubleshoot complex test failures, drive root cause analysis, and implement sustainable corrective actions.
• Evaluate and recommend next-generation test technologies to enhance inspection capability and plant efficiency.

Manufacturing & Process Engineering

• Design manufacturing processes, equipment layouts, machine sequences, and material handling systems for maximum efficiency.
• Adapt equipment designs to factory and production conditions.
• Integrate statistical process control (SPC), quality inspection, and test requirements directly into production plans.
• Drive continuous improvement initiatives to optimize test yield, reduce cycle times, and minimize false rejection rates.
• Provide technical guidance to R&D engineering on design concepts and manufacturing feasibility.
• Ensure all processes, equipment, and procedures comply with safety, quality, and regulatory standards.

Leadership & Stakeholder Management

• Provide coaching, mentoring, and technical guidance to lower-level engineers and specialists.
• Manage major, complex technical projects with broad organizational impact, delegating and reviewing work products as needed.
• Serve as a primary technical point of contact for internal stakeholders, vendors, and Contract Manufacturers (CMs).

Required Qualifications

• Education & Experience:
• Bachelor’s degree in Mechanical, Electrical, Biomedical, or Manufacturing Engineering (or equivalent) with a minimum of 7 years of relevant experience, OR
• Advanced degree (Master’s or Ph.D.) with a minimum of 5 years of relevant experience.
• Direct hands-on experience with Pressure Decay Leak Testers and electrical/mechanical testing systems .
• Deep expertise in test equipment qualification (IQ/OQ/PQ) and validation (MSA, Gauge R&R) within regulated environments (FDA, ISO).
• Proven track record of managing complex technical projects with high autonomy and limited direct oversight.
• Able to cross the border to the Tijuana, Mexico site of our Contract MFR at least 3 days a week.

Preferred Qualifications

• Hands-on experience with industry-standard leak test equipment (e.G., Uson, Zaxis, Inficon, or equivalent).
• Knowledge of fluid dynamics, pneumatics, and hermetic sealing principles.
• Familiarity with alternative leak test methodologies (mass flow, helium, vacuum decay).
• Experience integrating Manufacturing Execution Systems (MES) with automated test equipment.
• Background in medical device manufacturing, particularly with pumps or infusion devices .
• Experience managing or supporting Contract Manufacturers (CMs) .
• Six Sigma Green Belt or Black Belt certification.