Job Description

JOB SUMMARY:

Leads and manages complex projects in the development, evaluation, improvement and implementation of manufacturing systems and methods to produce products within the medical, dental, and animal health markets. Utilizes expert knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods and quality control standards. Initiates and leads complex projects and collaborates with cross-functional teams to deliver innovative solutions and ensure the successful execution of projects.

ESSENTIAL/PRIMARY DUTIES:

• Leads strategic workforce optimization, space planning, workflow design and equipment layout for peak operational efficiency.
• Using advanced manufacturing knowledge, educates engineers on process capability, development of cost model, and the evaluation of process alternatives. Facilitates the development of new processes.
• Leads within the team and works with management on solving high risk issues.
• Leads process(es) and project(s) to specifications of equipment, material, and parts to enhance and solve problems.
• Leads sourcing changes from in-house to supplier and vice versa to meet demand and capability changes.
• Leads comprehensive product evaluations from a manufacturing perspective, ensuring adherence to specifications, quality standards and regulatory requirements. Provides expert guidance to cross-functional teams on process optimization, quality improvement initiatives and corrective actions.
• Embodies best practices, leads discussions, meetings and brainstorming sessions related to their assigned tasks. Makes decisions within assigned and escalates appropriately.
• Can analyze, target, and guide other engineers on cost, quality, and delivery improvement, and how to implement sustainable solutions.
• Develops best practices for documenting and maintaining work instructions.
• Leads development and design of component processes and tooling to ensure efficient production methods.
• Leads and develops industry standards and regulations for quality, safety, and performance.
• Learns established and new technical tools and methods. Proactively engages in bringing insight and implementation for new industry trends and new technologies.
• Utilizes a structured approach to problem-solving to improve and innovate production processes. Leads research and implementation of enhanced processes and capabilities.
• Analyzes and assesses complex part or assembly risk areas and teaches other engineers problem solving techniques to reduce the risk condition.
• Leads the development and process execution of technical documentation such as verification and validation protocols, CAPA’s, quality alerts and process FMEA’s.

SECONDARY DUTIES:

• Researches the latest developments and trends in discipline.
• Contributes ideas for process changes and improvements.
• Influences change within their discipline and peer group.

EDUCATION and/or EXPERIENCE:

Bachelor's degree in engineering or related field and 4+ years of relevant experience, or equivalent combination of both. Black Belt certification is preferred.

COMPETENCY and/or SKILL:

• Strong analytical and communication skills (written & verbal)
• Experience with tooling, fixture, and process design concepts
• Fundamental application of engineering tools and methods
• Ability to apply problem-solving skills to find root causes and propose solutions and lead investigations
• Experience with Microsoft Office, design, and other business software packages
• Comprehension of advanced product design methods
• Strong mathematical and technical abilities
• Ability to multitask and problem solve
• Ability to lead by influence throughout the organization
• Proficient in the subject matter or the functional areas
• Ability to lead and manage projects and/or project teams
• Knowledge of FDA and ISO regulations
• Ability to generate detailed and high-quality technical documentation
• Proficient in the design of complex systems and identifying new technological opportunities
• Ability to analyze and assess complex technical risks associated with projects
• Expert in the subject matter or the functional areas of the assignments and influence the project team for the best practices related to that area
• Ability to lead by influence cross functionally throughout the organization and lead change management processes
• Ability to lead the design of complex, interconnected systems and shape the organization's technical direction

SUPERVISORY RESPONSIBILITIES:

• Provides leadership, coaching and/or mentoring to co-op’s, technicians, level I, and level II engineers. May act as a lead or first-level supervisor.