Principal Manufacturing Engineer – Pressure Decay Leak Testing & Test Systems

Planet Pharma; San Diego (CA); On-site; USD 177,000 - 218,000; Full time

Job summary

Planet Pharma in San Diego, CA seeks a technical specialist with deep expertise in pressure decay leak testing and electrical-mechanical testing systems to lead design, validation, and optimization across manufacturing lines.

The role includes defining test specs with R&D, Quality and Regulatory, developing IQ/OQ/PQ programs, and driving continuous improvements to test yield and cycle times in a medical device environment.

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 development & validation of electrical-mechanical testing systems.
• Familiarity with MES 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.

Responsibilities

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapts machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensures processes and procedures are in compliance with regulations.

Skills

Leak test equipment

Fluid dynamics

Pneumatics

Electrical-mechanical testing

MES integration

Six Sigma

Medical device environment

Contract manufacturers support

Alternative leak test methods

Infusion devices

Education

Baccalaureate degree

Tools

Uson

Zaxis

Inficon

MES (Manufacturing Execution Systems)

Job description

Pay 85-105 depending on 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

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 o 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

Responsibilities may include the following and other duties may be assigned.

• * Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• * Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• * Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• * Adapts machine or equipment design to factory and production conditions.
• * May incorporate inspection and test requirements into the production plan.
• * Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• * Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
• * Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• * Ensures processes and procedures are in compliance with regulations.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is 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. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from 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 immediate job area.

Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.

Communication and Influence: Represents 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 job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Required Knowledge and Experience: 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 for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.