Summary of Responsibilities

The Production Engineer reports to the Production Manager and will be the point person for calibration, maintenance and repair of Production Systems and Equipment. The Production Engineer will lead and oversee manual and semi-automatic manufacturing processes to support production operations. The Production Engineer will be responsible for writing and executing Equipment, Process, and Product Validations. The Production Engineer will lead the completion of process development/process characterization, new product commercialization or other related projects.

Essential Duties and Responsibilities

· Complete maintenance and calibrations tasks for manufacturing equipment

· Develop, lead, and execute equipment and process validations (including the design of specifications, IQ, OQ, and PQ). Author validation summaries, reports and complete risk assessments.

· Execute various manufacturing processes (involving precise measurement, step-by-step instructions, packaging, and quality control testing) for products used for internal Clinical Lab Developed Tests and external IVD products

· Ensure adherence to standard operating procedures, work instructions, current Good Manufacturing Practices (cGMP), safety policies and procedures

· Document manufacturing and testing with adequate details in reports and batch records using Good Documentation Practices (GDP)

· Facilitate the transfer of new products from Research and Development to the Production Department

· Revise work instructions, specifications, and SOPs within document control using change control

· Interface with external vendors (calibration providers, material suppliers, equipment suppliers).

· Other duties as assigned.

Qualifications

· Bachelor's Degree in Biomedical, Chemical or Mechanical Engineering or related field.

· Strong computer skills (competency with Microsoft Office, Statistical Analysis)

· Exceptional problem solving abilities

· Ability to work both as part of a team or individually/independently

· 2 plus years of experience working in regulated manufacturing environment

· Basic statistics knowledge, including data analysis and hypothesis testing

MiraVista Diagnostics is an Equal Opportunity Employer.

Job Type: Full-time

Pay: $70,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Application Question(s):

• Are you an Indiana Resident?

Education:

• Bachelor's (Required)

Experience:

• Biomedical, Chemical, or Mechanical Engineering: 2 years (Required)

Work Location: One location

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