Principal Process Engineer

DLTalent has partnered with a medical device manufacturer, who specializes in drug delivery products, to hire a new team member as a Sr. or Principal Process Engineer. The employer has roots in the Midwest and is currently growing as they prepare to launch new products out of their CA facility later this year.

The Process Engineer will have the following responsibilities:

• Support both new and legacy manufacturing lines, keeping a focus on optimization across both lines
• Work directly with clients to improve existing lines
• Drive improvement initiatives across formulation, filling and packaging equipment
• Identify and recommend programs within manufacturing which will improve quality, safety and service
• Lead and ensure installation qualifications (IQ) and operational qualifications (OQ) are successfully executed
• Develop process validation protocols and author technical reports
• Mentor and coach junior level staff

Candidates who will find this job both interesting and challenging will have the experience below:

• Bachelor's degree in Engineering
• Experience working in the medical device industry is highly preferred, but we are open to candidates who have worked in other high volume FDA regulated manufacturing environments (Food, Animal health, Electronics etc)
• Experience working in high volume manufacturing is required
• At least 10 years of experience in project or manufacturing engineering with significant knowledge in process development
• Small parts handling is required
• Process Validation - able to develop, write and execute protocols
• Experience installing and qualifying equipment
• Knowledgeable in Continuous Improvement (CI)
• Exposure to new product introduction (NPI)
• Experience with DMAIC and CAPA is preferred
• Familiarity with PLC is preferred
• Aspires to mentor or lead teams
• Strong communicator

Additional Benefits:

• Medical / Dental / Vision
• Paid Time Off, Personal Time Off, Company Holidays
• 401K (with match)
• Employee Resource Groups