Engineer - Pen Device Development MSAT
Civica

About Civica:

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica's plans and progress at www.civicarx.org

Job Description

The engineer will be responsible for Design Transfer of injection pen specifications and manufacturing processes into Petersburg site. As the accountable SME, provide support the commercial assembly process control strategy throughout the product lifecycle.

Essential Duties and Responsibilities:

• Draft, Qualify and Transfer device and combination product test methods in Petersburg site. Methods to include:
  • Incoming inspection (Cartridge and pen components)
  • Dimensional measurements
  • Functional tests including dose accuracy, force test, etc.
• Finalize control plans, specifications, justification of specs, sampling.
• Support fabrication of fixtures and inspection aids to assist device assembly process.
• Build & Test Pens for Eng Studies, Comparability Analysis, Design Verification, Stability, etc.
• Own customer complaint analysis:
  • Develop inspections and test methods for returned pens.
  • Write technical reports for common issues that can be referenced for future investigations.
• Manage site-related change controls coming from site or supplier changes, etc.
• Support deviations related to the pen assembly manufacturing process.

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Industrial Design, Biotech or a related field.
• 4+ years of experience in medical device manufacturing, development or a similar field.
• Excellent problem-solving abilities and attention to detail.
• Strong communication and teamwork skills.
• Ability to manage multiple projects and meet deadlines.

• A Master's degree or relevant certifications are a plus.
• Familiarity with CFR 820 device regulations and relevant regulatory guidance's.
• Proficiency in simulation and statistical analysis tools.
• Experience with regulatory inspections.