Engineer II, Manufacturing

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging whats possible and making headway to help improve outcomes.

Provide technical and engineering support to the Operations Department. Support new product Introduction activities. Design equipment and floor layouts. Act as the subject matter expert (SME) for assigned product lines which includes supporting audit activities and first response for shop floor issues. Support shop floor activities and work with operators as required to complete daily operational targets. Responsibilities include:

Equipment and process improvement projects.

Support the introduction of new processes or equipment into the manufacturing facility.

Assist with investigational activities around non-conformances to established standards, specifications, or procedures.

Operator training and operating procedure/batch record development.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Understand and be knowledgeable of equipment and process operations completed in the facility. This includes, site standard operating procedures (SOPs), equipment documentation, capacity, setup, operation, disassembly, maintenance, cleaning, troubleshooting, monitoring, and programming of manufacturing equipment at the facility.

Effectively start, stop, and operate all equipment and act as equipment SME.

Perform testing and troubleshoot equipment to determine functionality level and capacity.

Create, update, and maintain equipment service work instructions. Support Equipment related Quality Investigations and Initiatives.

Document investigation activities around events/non-conformances or customer complaints with effective root cause identification.

Partner with Quality Assurance and other support groups to resolve process related deficiencies and material/product disposition.

Create or revise controlled documentation as required.

Lead training initiatives for new and existing operators participating in manufacturing operations.

Perform Development and Design Work

Assist in the transfer of processes and/or equipment into development or production.

Work with Product Development and Management staff on process development and validation activities.

Work with facility and management team to design appropriate floor layouts and drawings.

Process Improvement and Validation

Organize, write, and execute validation protocols associated with the manufacturing process.

Lead and support troubleshooting activities to minimize process downtime or re-occurrence of production issues.

Identify key process indicators and collect data to drive manufacturing and yield improvements.

DESIRED MINIMUM QUALIFICATIONS:

Bachelors degree in engineering or similar technical field or equivalent with 3-5 years of experience in the Medical Device industry or similar industry, masters degree with 0-2 years of experience.

Ability to read blueprints, electrical & pneumatic schematics.

Excellent verbal and written communication skills.

Strong technical writing abilities.

Demonstrated organizational and communication skills.

Excellent trouble shooting and problem-solving skills.

Demonstrated computer knowledge of Microsoft Office.

Must read, write, and speak in English, and communicate clearly and concisely.

Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other National and International regulations and standards. Clean room experience is a plus.

Understanding of Lean/Six Sigma a plus.

CAD experience (Solidworks and AutoCAD) a plus.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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