|Job Summary: Plan, develop and execute projects that comply with the goals of the company. Develop/execute IQ/OQ/PQ. Develop SOP and work instructions. Work with all departments to develop and implement cost savings and capital projects. Manage projects of intermediate to complex scope. Develop CAD models and/or drawings of proposed or modified equipment and processes. Work with vendor to develop custom machinery or modifications to existing machinery.
Duties and Responsibilities:
Design and develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures, which are consistent with a zero defect level as well as low product cost.
Coach and mentor junior engineers and associates with regard to manufacturing engineering activities.
Perform process validation activities on all manufacturing processes.
Support prototype and pilot production of new products, product changes, and enhancements.
Work with product development staff to ensure that products under development are designed for manufacture. Work toward resolution of manufacturing issues.
Develop cost analysis and cost improvements.
Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
Responsible for writing procedures, product specifications and standards.
Responsible for generating, executing and reporting process specification, validation qualification protocols.
Utilize Lean Six Sigma (LSS) tools and concepts to assist in process improvements, both within Lydall, and externally at our customers/suppliers.
Responsible for tooling design and procurement.
Perform other related job functions as needed to reach results.
Provide engineering and technical support to production units.
Must be knowledgeable in the effective use of Lean Six Sigma (LSS) tools and concepts to assist in process improvements, both within Lydall, and externally at our customers/suppliers.
Serve as an active participant in LSS programs that promote continuous improvement.
Must adhere to all company policies and safety rules.
Must be able to work extended hours when required.
Education, Experience, Skills and Abilities Required for Consideration as a Candidate:
Min: 4 year BSME
Proficient computer skills using MS office, MS Project
Strong analytical, organizational and communication skills.
Independent self-starting work habits.
Education, Experience, Skills and Abilities Preferred:
2 to 5 years of related experience in a regulated environment
Experience with ISO 13485 and FDA guidelines.
Six-sigma training a plus
Total Work Systems-lean Six-Sigma
Quantity & Output of Work
Timeliness of Delivery of Output
Quality of Work
Use of Resources
Customer Impact/Value Added
Freedom from Unplanned Support
Productive Work habits
Adding Skills & Capabilities
Alignment & Compliance
State or Province