Engineer 1, Sustaining

Cook Medical; Indiana (PA); On-site; USD 80,000 - 110,000; Full time

Job summary

Cook Inc. Spencer is seeking a Sustaining Engineer to lead product and process remediation and sustain ongoing activities for existing products.

The role requires cross-functional coordination, risk analysis, and adherence to design controls under 21 CFR 820 and ISO standards, with opportunities to mentor technicians and contribute to continuous improvement.

Qualifications

• Bachelor's degree in Engineering or Engineering Technology, or equivalent background.
• Previous project management experience preferred.
• Knowledge of statistical practices related to sample sizes, confidence intervals, capability, risk assessment, and problem solving.
• Knowledgeable with Windows-based software (Word, Excel, Project, PowerPoint, Visio).

Responsibilities

• Interface with multiple engineering, regulatory, quality and operations groups to progress projects.
• Manage multiple project timelines, resources, and responsibilities to achieve goals.
• Analyze risk using appropriate methods and standards.
• Follow design control procedures and comply with 21 CFR 820, ISO 13485, and ISO 14971 as applicable.
• Identify user needs and develop design input requirements.
• Formulate verification and validation test plans and collaborate with Cook departments to execute testing.
• Update device and production specifications accordingly.
• Mentor/coach technicians or other engineering employees as needed.

Skills

Engineering degree

Project management

Statistics knowledge

Education

Bachelor's degree in Engineering or Engineering Technology

Tools

Windows software

Job description

Overview

The Sustaining Engineer at Cook Inc. Spencer will lead product and process remediation efforts, in addition to performing sustaining activities for commercially available products.

Responsibilities

• Interface with contract engineers, development engineering, production engineering, product management, regulatory, clinical, quality engineering, quality assurance, operations, sourced vendors, and physicians as necessary to progress projects/tasks.
• Manage multiple project timelines, resources, and responsibilities to achieve team, departmental, and company goals.
• Analyze risk using CEA and current FMEAs.
• Follow design control procedures and comply with requirements of 21 CFR 820 Quality System Regulations, ISO 13485, and ISO 14971 as applicable.
• Identify user needs and develop into design input requirements.
• Formulate verification and validation test plans and collaborate with other Cook departments to execute testing.
• Update device and production specifications accordingly.
• May mentor/coach technicians or other engineering employees (co-ops/interns).

Qualifications

• Bachelor's degree in Engineering or Engineering Technology, or equivalent background.
• Previous project management experience preferred.
• Knowledge of statistical practices as it relates to sample sizes, confidence intervals, capability, risk assessment, and problem solving.
• Knowledgeable with Windows-based software (Word, Excel, Project, PowerPoint, Visio).

We are an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class. Cook will consider qualified applicants with criminal histories in a manner consistent with applicable federal, state/province, and local law.