Engineer II Process – Controls

About the role

Performs analyses to develop design specifications and performance requirements. Provides technical information concerning manufacturing or processing techniques, materials, properties and process (advantages/limitations) engineering planning. Selects techniques to solve problems and make sound design recommendations.

Responsibilities

• Establishes processes based on product specifications.
• Evaluates process and design alternatives based on “design for manufacturability” principles.
• Understands principles of “Cost of Goods Sold”.
• Manages program compliance with “Quality Control” requirements (i.e. Design Control, Process validation etc.).
• Understands IP issues relative to processes being developed.
• Maintains knowledge of new developments in manufacturing and design technologies.
• Understands work environment issues (i.e. OSHA regulations, etc.).
• Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Qualifications

• Bachelor’s Degree (± 16 years) in Engineering or Technical Field.
• Minimum 2 years (2 – 4 years) manufacturing experience.
• Experience designing and testing medical devices required.
• Experience developing manufacturing processes and technologies and designing for manufacturability required.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in a timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel, including internationally.

Pay

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.