Principal Manufacturing Engineer - Pressure Decay Leak Testing & Test Systems

Lancesoft; San Diego (CA); On-site; USD 120,000 - 165,000; Full time

Job summary

LanceSoft is seeking a Technical Specialist in San Diego to advance leak-test systems across manufacturing lines. The role focuses on design, validation, and implementation of test equipment from concept through production, compliant with FDA/ISO standards.

You will collaborate with R&D, Quality, and Regulatory teams to ensure robust testing, process improvements, and equipment performance in a medical device environment.

Qualifications

• Must have strong background in pressure decay leak test system design and validation.
• Experience with IQ/OQ/PQ in compliance with FDA and ISO regulations.
• Ability to lead process development and validation activities for test equipment.
• Familiarity with conducting MSA/Gauge R&R studies.

Responsibilities

• Design manufacturing processes and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Define test specifications, acceptance criteria, and test parameters with R&D, Quality, and Regulatory teams.
• Lead the process development, qualification, and validation of test equipment (IQ/OQ/PQ).
• Develop and execute validation studies including repeatability and reproducibility.
• Drive continuous improvement to optimize test yield, cycle time, and rejection rates.

Skills

Technical leadership

Analytical thinking

Problem solving

Regulatory awareness

Education

Bachelor's degree or equivalent

Advanced degree (MS/PhD)

Tools

Uson

Zaxis

Inficon

MES integration

Job description

Join our team in San Diego, CA, a vibrant city known for its beautiful beaches, diverse culture, and thriving tech industry.

We are looking for a dedicated professional to contribute to our manufacturing processes and enhance our production capabilities.

Responsibilities

• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Create efficient and productive machine arrangements within plant facilities.
• Design sequences of operations and specify procedures for fabricating tools and equipment affecting product performance.
• Adapt machine or equipment design to factory and production conditions.
• Incorporate inspection and test requirements into the production plan.
• Inspect machinery, equipment, and tools to verify efficiency and initiate corrective actions to ensure product quality.
• Develop manufacturing processes applicable to statistical process control and may develop those techniques.
• Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensure processes and procedures comply with regulations.

Technical Specialist Career Stream

This role is an individual contributor position with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. You will formulate, deliver, and/or manage assigned projects and work with other stakeholders to achieve desired results. You may act as a mentor to colleagues or direct the work of lower-level professionals. The majority of your time will be spent delivering R&D, systems, or initiatives related to new technologies or therapies -from design to implementation - while adhering to policies, using specialized knowledge and skills.

Differentiating Factors

Autonomy: Recognized expert, managing large projects or processes with considerable latitude in determining deliverables, with limited oversight from a manager. Coaches, reviews, and delegates work to lower-level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of the immediate job area. Innovation and Complexity: Faces difficult, moderately complex, and undefined problems and issues requiring detailed information gathering, analysis, and investigation. Develops solutions to moderately complex problems and implements solutions to enhance performance. Communication and Influence: Represents the organization as a primary contact for specific projects and initiatives;communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement and influence decision-making. Leadership and Talent Management: Typically provides guidance, coaching, and training to other employees within the job area. Manages major/moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Job Requirements

Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a Baccalaureate degree (or equivalent) and a minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience.

• Serve as the primary subject matter expert for pressure decay leak test system design, implementation, validation, and optimization across manufacturing lines.
• Define test specifications, acceptance criteria, and test parameters in collaboration with R&D, Quality, and Regulatory teams.
• Lead the process development, qualification, and validation of test equipment (IQ/OQ/PQ) in compliance with FDA and ISO regulations.
• Develop and execute test method validation studies, including repeatability, reproducibility, and measurement system analysis (MSA/Gauge R&R).
• Drive continuous improvement initiatives to optimize test yield, cycle time, and false rejection rates.
• Evaluate and recommend new test technologies and methodologies to enhance inspection capability and manufacturing efficiency.
• Troubleshoot and resolve complex test failures, driving root cause analysis and implementing sustainable corrective actions.

Preferred Qualifications

• Hands-on experience with industry-leading leak test equipment (e.G., Uson, Zaxis, Inficon, or equivalent).
• Experience with fluid dynamics, pneumatics, and hermetic sealing principles.
• Experience in the development & validation of electrical-mechanical testing systems.
• Familiarity with MES (Manufacturing Execution Systems) integration with test equipment.
• Experience supporting Contract Manufacturers in a medical device environment.
• Knowledge of alternative leak test methodologies (e.G., mass flow, helium, vacuum decay).
• Six Sigma Green Belt or Black Belt certification.
• Experience with pump or infusion device manufacturing.

EEO

EEO Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.