Principal Manufacturing Engineer Pressure Decay Leak Testing & Test Systems

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.

• 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.

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.

• 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.

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. Experience required in Pressure Decay Leak Testers and electrical/mechanical testing systems:

• 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.

• 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.

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.