Process Engineer - Medical Devices III

Responsibilities:

Responsible for designing and implementing manufacturing processes which are compliant with FDA/ISO Quality Systems regulations for Medical Devices. Familiar with a variety of field concepts, practices, and procedures.

Relies on experience and judgment to plan and accomplish goals. Performs a variety of tasks.

At higher levels, may lead and direct the work of others.

A wide degree of creativity and latitude is expected.

Experienced position that requires a Bachelors or Master's degree and 5-8 years of experience.

This position typically reports to an Engineering Team Leader or a Production Team Leader.

The employee receives direction in the form of broadly defined objectives. Responsibilities include meeting team objectives in safety, quality, cost, delivery, employee engagement, asset management, team development, and supervision of other employees as needed.

The employee is recognized for technical knowledge in process engineering and works within the technical team structure supporting trial and capital to the purpose of expanding our innovation capability, while providing flexibility and personal/organizational sensitivity. Dimensions Vary widely with assignment and typically include:

Project responsibility

Project team of 3 to 15 people

Single or multiple projects Job Position Accountabilities / Expectations

Requirements:

Safety: Promotes and participates in mill loss control management by utilizing Safety Principles, Lean / Six Sigma Manufacturing Principles, and compliance with all local, state, and federal regulations.

Environmental & Health: Comply with local, state, and federal environmental regulations as defined by mill policies, procedures, employee training, ISO 14001, and site subject matter experts.

Quality: Improve process capability to deliver a reduction in defects and variability. Identify, develop, and implement products, processes, materials, systems, and procedures to achieve business objectives and adhere to federal regulations.

Diversity: Provide leadership and supervision in a way that helps the organization attract, develop, and retain the best people and fosters

Design and Development: Lead the initiation, design, and development of manufacturing, converting, and supporting processes to achieve unit objectives.

Technical Knowledge: Develop knowledge and skills to be recognized for expertise and guidance in application of engineering and maintenance principles.

Security and Documentation: Provide guidance in security and documentation to ensure the retrieval of data and protection of proprietary information.

Problem Solving: Seek, recognize, define, and solve problems/opportunities to achieve unit objectives.

Internal Control: Lead assigned projects/tasks to meet unit objectives within applicable corporate policies. Place emphasis on CFI and Internal Control

Communications: Communicate fully with supervisors, subordinates, and others. Be informative without being obtrusive or vexatious. Communicate in a way that is timely, yet prompt; complete, yet concise; candid, yet accurate; and clear, yet responsive.

Human Resource Development: Provide supervision and/or assist in the development of others in the area of incumbent's expertise.

Controlling: Develops specific action plans for critical work, adheres to the plan, anticipates problems, and makes appropriate modifications to the plan as necessary. Holds others accountable for their specific deliverables within the plan. Key Relationships / Customer Expectations (Optional) Customers Manufacturing Team, Converting Team, Leadership Team, Staff Resources. Expectations

Provide process engineering support on resolution of process and equipment problems

Provide guidance on process and qualification trials