Principal Engineer, Reagent Engineering

Biofire Diagnostics • Hazelwood, MO

435d

About The Position

The Principal Engineer, Reagent Engineering will lead and manage equipment-related projects within the Reagent Engineering Equipment Project team at bioMérieux. This role focuses on providing technical expertise and project management for manufacturing equipment used in producing complex medical devices, ensuring optimal manufacturing processes and compliance with regulations.

Requirements

• Bachelor's Degree in a technical field with 8+ years of engineering experience preferred.
• High School Diploma with 12+ years of engineering experience also accepted.
• Technical Certification / Associates Degree with 10+ years of engineering experience also accepted.
• Master's Degree with 5+ years of engineering experience also accepted.
• 5+ years of experience working with automated processes and machinery.
• Strong ability to use Solidworks / AutoCAD programs.
• Solidworks PDM experience is preferred.
• Project Management experience is preferred.
• Ability to collaborate professionally in a cross-functional team environment.
• Knowledge of FDA/ISO regulations and equipment validation is preferred.
• Strong knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook).
• Strong communication and interpersonal skills.
• Strong analytical and problem-solving skills.

Nice To Haves

• Experience in the in vitro diagnostics field.
• Familiarity with medical device manufacturing processes.

Responsibilities

• Lead and manage equipment-related projects.
• Provide Solidworks / AutoCAD expertise related to equipment design and modification.
• Act as administrator for Solidworks PDM system.
• Develop documentation such as equipment master records, equipment drawings, and parts lists.
• Manage change control process and compliance-related documentation for projects.
• Collaborate with Manufacturing, Purchasing, and Quality to lead projects and ensure optimal manufacturing processes.
• Organize and lead meetings to support project timelines.
• Develop and submit CAPEX requests for projects as required.
• Address unplanned requests for Engineering support as directed by management.
• Support projects or tasks to keep manufacturing running and ensure quality products are shipped to customers.
• Evaluate new technologies.
• Participate in the development of long-term strategies for equipment and process improvements.
• Drive continuous improvement of manufacturing equipment.

Benefits

• Health insurance coverage.
• 401k retirement savings plan.
• Paid holidays and vacation time.
• Professional development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Industry: Computer and Electronic Product Manufacturing
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees