Job Title: Process Engineer II

Location: Spencer, IN (Onsite)

Duration: 9 Months on w2

Job Description:

Manager needs 2-4 years of industry experience post-graduation with at least 1 year in the medical device industry.

Candidates must be proficient with creating IQ, OQ, PQ protocols.

Process characterization and validation experience.

Independent worker

Problem solving abilities.

This person will be working on a new product accessory for a valve replacement device.

Job Purpose

Develops products, materials, processes, or equipment for projects of moderate complexity.

Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.

Key Responsibilities

Fully participates in and successfully contributes to project teams typically including the following activities: product design and development, test of materials, preparation of specifications, process capability studies, research investigations (animal and clinical studies), report preparation, and process/test documentation.

Works independently to plan and schedule own activities necessary to meet timelines.

Designs and coordinates standard engineering tests and experiments.

Designs, procures, and fabricates tooling and fixtures.

Performs troubleshooting on new products/process problems as related to design, material, or process.

Summarizes, analyzes, and draws conclusions from test results.

Prepares standard reports/documentation to communicate results to technical community.

Responsible for engineering documentation.

Invents/ creates concepts and designs for new products/processes and submits idea disclosures.

May train and/or provide work direction to technicians.

Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.

Demonstrates PDP/TPD system knowledge through delivery of high-quality deliverables.

This person will be working with a team of approximately 5 people. There are approximately 40 people in dept.

Quality Systems Duties and Responsibilities:

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications:

BS degree in engineering; preferably ME, Biomed, Polymer Science, Chem Engr. with science background

Also, 2-4 years of experience

Independent

Must have medical device experience.

Must have process validation experience.

Problem solving capabilities.

Must either have SolidWorks, or similar.

Analytical

Proficient in Microsoft apps

Must have Minitab experience.

Windchill experience - preferred

Thermoplastic experience - highly preferred

Understanding of GD&T Geometric Dimensioning and Tolerancing,