Manufacturing Engineer II

JOB SUMMARY:

Responsible for the development, evaluation, improvement and implementation of manufacturing systems and methods to produce products within the medical, dental, and animal health markets. Utilizes knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods and quality control standards. Works on complex projects, often taking the lead on specific aspects, and collaborates with cross-functional teams to deliver innovative solutions and ensure the successful execution of projects.

ESSENTIAL/PRIMARY DUTIES:

• Drives strategic workforce optimization, space planning, workflow design and equipment layout for peak operational efficiency.
• Applies manufacturing knowledge to effectively estimate the cost of process alternatives and documents and implements the most effective solution. Participates in the development of new processes.
• Serves as an active contributor within the team and escalates issues to management when needed.
• Collaborates and drives specifications of equipment, material, and parts to enhance and solve problems.
• Collaborates in sourcing changes from in-house to supplier and vice versa to meet demand and capability changes.
• Evaluates products from a manufacturing perspective based on specifications and quality standards.
• Follows best practices, actively engages in discussions in meetings and brainstorming sessions related to their assigned tasks. Makes decisions within assigned tasks under guidance and escalates appropriately.
• Identifies cost, quality and delivery improvement opportunities and implements effective and sustainable solutions.
• Leads documentation and maintenance of work instructions.
• Collaborates with internal and external resources to develop and design component processes and tooling to ensure efficient production methods.
• Follows industry standards and regulations for quality, safety, and performance.
• Learns established and new technical tools and methods.
• Utilizes a structured approach to problem-solving to improve and innovate production processes.
• Identifies part or assembly risks and applies problem solving techniques to reduce the risk condition.
• Authors and executes technical documentation such as verification and validation protocols, CAPA’s and quality alerts.

SECONDARY DUTIES:

• Contributes ideas for process changes and improvements.
• Influences change within their discipline.

EDUCATION and/or EXPERIENCE:

Bachelor's degree in engineering or related field and 2+ years of relevant experience, or similar combination of both.

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 basic 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

SUPERVISORY RESPONSIBILITIES:

• Provides leadership, coaching, and/or mentoring to co-op’s, technicians, and level I engineers.