Job Details

Target PR Range: 33-43/hr DOE

Summary:
The main function of a manufacturing engineer is to apply knowledge of technical principles and systems/procedures to optimize manufacturing processes. We are seeking a Senior Manufacturing Engineer to lead equipment qualification and validation activities for a custom-built processing system (TTU) operating in a clean room environment. This role is ideal for a hands-on engineer with deep IQ/OQ/PQ experience in regulated manufacturing who can plan, coordinate with vendors, and execute validation protocols with precision.

Job Responsibilities:
* Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills
* Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
* Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
* Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
* Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
* Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
* Other incidental duties assigned by Leadership
* Lead installation, operational, and performance qualification (IQ/OQ/PQ) activities for the TTU — a custom rotational oven system used in clean room manufacturing
* Validate rotational speed parameters and ensure proper protocol execution on the equipment
* Define user requirements for equipment operating in intrinsically safe environments involving flammable and explosive chemicals
* Collaborate with outside vendors on equipment design work, reviewing designs for technical completeness and identifying gaps
* Develop validation plans and execute against them with strong attention to detail and schedule adherence
* Support commissioning and qualification of clean rooms and processing equipment
* Partner with cross-functional teams and project stakeholders to deliver qualification milestones on time

Skills:
* Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
* Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
* Basic understanding of statistical techniques
* Previous experience working with lab/industrial equipment required (if applicable)
* Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
* Solid problem-solving, organizational, analytical and critical thinking skills
* Solid understanding of processes and equipment used in assigned work
* Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
* Knowledge of applicable FDA regulations for medical device industry
* Strict attention to detail
* Ability to interact professionally with all organizational levels
* Ability to manage competing priorities in a fast-paced environment
* Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
* Ability to build productive internal/external working relationships
* Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Required Qualifications:
* Bachelor’s degree in engineering (Mechanical, Chemical, Manufacturing, or related field)
* Strong hands-on experience with equipment validation — specifically IQ/OQ/PQ protocols
* Background in regulated manufacturing environments (medical devices, pharmaceuticals, or similar)
* Experience working in or supporting clean room environments
* Demonstrated ability to create detailed plans and execute them methodically
* Familiarity with intrinsically safe / hazardous area classifications and the ability to set appropriate user requirements for flammable or explosive chemical environments
* 2-4 years experience required.