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SUMMARY

The Reliability Engineering Manager oversees a multidisciplinary team responsible for the technical and administrative leadership of technology transfer and GMP manufacturing of medical devices at the Collagen Manufacturing Center (CMC). This role is also responsible for multidisciplinary process selection, optimization activities, troubleshooting, and ongoing Process and Product Qualification. The Reliability Engineering Manager develops and implements plans for continuous improvement, manufacturing sustainability, conservation of critical utilities, and Asset Lifecycle Management. This role works closely with the Project Engineering Manager to specify, modify, or acquire equipment necessary to achieve supply chain goals. The Project Engineering Manager ensures that technology transfer and manufacturing improvements protect the identity, quality, durability, reliability, safety, and effectiveness of medical devices and, thereby, protect patient safety.

SUPERVISION EXERCISED

Direct supervision is exercised over staff assigned to technology transfer, process improvement, and process/facilities/equipment validation teams. Indirect supervision is partnered with multidisciplinary teams to ensure that processes meet their intended goals and are executed with quality, coordination, and compliance.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Collaborate with broad multidisciplinary teams in the identification, definition, elucidation of key objectives, assignment of responsibilities, change management, process engineering protocols, protocol execution, receipt of data, analysis, recommendations, final reports, final approvals, and regulatory submissions.

• Apply Best Engineering Practices to address the key objectives and providing impact statements to budgets, quality, regulatory compliance, and supply chain.

• Collaborate and communicate frequently with multidisciplinary teams regarding the process engineering phases of planning, change controls, protocol authorship/approvals, protocol execution, coordination with stakeholders, discrepancies/issues, report generation, and process engineering closeouts.

• Apply optimization efforts to sustainability, conservation of critical utilities, consumption of supplies, asset lifecycle management, reduction of waste, maximization of yields, and 6S initiatives.

• Trouble shoot process or equipment/facilities issues affecting supply chain and safety/efficacy/purity of product produced at the CMC. Work with a cross-functional team considering all facets of a manufacturing process including raw materials, specifications, measurements, equipment/facilities, manpower, and environmental factors.

• Partner with Project Engineering in the User Requirement Specifications planning of new, repaired, restored, and/or replaced equipment/facilities.

• Provide leadership in Root Cause Analysis, non-conformance protocols, and CAPAs.

• Support and encourage utilization of automated systems in new equipment/process delivery and existing processes.

• Provide technical coaching, professional mentoring, training, and career support for direct teams and other stakeholders pursuing an engineering or management career path; prepare succession management plans for key positions identified in the department.

• Responsible for safety culture, awareness, and accountability within the multidisciplinary teams

DESIRED MINIMUM QUALIFICATIONS

• Bachelor's degree in Engineering or relevant technical science, or military experience equivalent.

• 5+ years of process engineering experience in the FDA regulated industries.

• 2+ years of management of process engineering departments.

• Demonstrated successes in the achievement of process engineering initiates in a multidisciplinary role.

• Lean certification is preferred.

• Six Sigma certification is preferred.

• Knowledgeable in various off-the-shelf software applications (MS Office, MS Project, CAD) and customized systems (CMMS)

• Knowledgeable in setting and following budgets.

• Demonstrated abilities to enhance staff talent and careers through mentorship and training.

• Strong problem-solving and analytical skills

• Ability to communicate effectively at all levels (both oral and written) both to in-house and external officials, where required.

• Solid regulatory compliance knowledge (GMP, OSHA, etc.)

• Medical device project engineering preferred.

• Demonstrated ability to provide high-level customer service.

TOOLS AND EQUIPMENT USED

Computer, measurement tools, diagnostic tools.

PHYSICAL REQUIREMENTS

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, and speak. The employee is required to go to all areas of the company including climbing ladders, manipulating tools, using a keyboard, discerning colors, reading displays, hearing sounds, and smelling odors. The employee may be required to periodically lift and/or move up to 60 lbs.

The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

ADVERSE WORKING CONDITIONS

Adverse exposure may result from the handling of hazardous and bio-hazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, dust, moving machinery parts, and medical wastes. The employee must be able to use Personal Protective Equipment including dust masks or respirators, and hearing and eye protection, The employee may have proximity to 480-volt electricity, high pressures including hydraulic pressure, vacuum, very cold temperatures, heights, and confined spaces.

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position.

SELECTION GUIDELINES

Formal application, rating of education and experience; oral interview and reference check; job related tests may be required .

DISCLAIMER

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

The job description does not constitute and employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

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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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

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