MiraVista Diagnostics is hiring a Production Engineer to join our team. This is a full time position at our Indianapolis facility.
If you’re interested in joining the MiraVista team, please apply for the Production Engineer position using the form on our website Career Center or email your resume to email@example.com if you have any problems with the web form.
The Production Engineer, while reporting to the Production and Engineering Manager, will be a central company-wide team member and point person for the maintenance, repair, calibration, risk assessment, validation, product and process engineering, and material management. The Production Engineer will lead and oversee manual and semi-automatic manufacturing processes to support uninterrupted company operations.
The incumbent will be work alongside the Production Manager to aid with the verification, validation, operation, and maintenance of equipment for the Production, Research and Development, and Clinical Services Departments (including facility-wide utilities). This individual will be an integral part of facilitating manufacturing, labeling, packaging, and distribution of high quality clinical diagnostic reagents and in vitro diagnostic medical devices.
Additionally, the Production Engineer will work to maintain the facility through materials management, including inventory control, material purchasing, receiving, and QC and acceptance testing. The incumbent will lead the completion of process development/process characterization, new product commercialization or other related projects.
- Develop, lead, and execute equipment and process validations (including the design of specifications, IQ, OQ, and PQ). Author validation summaries and reports.
- Lead maintenance and calibrations tasks for manufacturing equipment across entire company
- Provide maintenance support and troubleshooting for the company as a first-attempt before outsourcing repairs
- Lead various manufacturing processes (involving precise measurement, step-by-step instructions, packaging, and quality control testing) for over 100 novel products, including internal Clinical use and external IVD products
- Ensure adherence to standard operating procedures, work instructions, current good manufacturing practices, safety policies and procedures
- Document manufacturing and testing with adequate details in reports and batch records
- Support the development and maintenance of the inventory central store, including purchasing, inventory control, bill of material generation, and material storage requirements
- 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
- Develop process maps for large processes and optimize to improve yield, time usage, and scheduling
- Support the implementation and use of the company-wide ERP for manufacturing, accounting, and inventory control
- Aid the Production Manager in ISO 13485 and other applicable audits.
- Interface with external vendors (calibration providers, material suppliers) and customers in a professional manner
- Excellent written, verbal, and interpersonal skills
- Demonstrate a team-player mindset and external disposition in the workplace
- Ability to mesh with the MiraVista culture and attitude
- Strong computer skills (competency with Microsoft Office, Statistical Analysis)
- Outstanding attention to detail in following procedures, completing documentation, and maintaining proper technique
- Strong technical aptitude
- Exceptional problem solving abilities
- Ability to work both as part of a team or individually/independently
- Qualified candidates must be legally authorized to be employed in the United States
- Bachelor’s Degree in Biomedical Engineering, Biomedical Engineering Technology, Mechanical Engineering, Mechanical Engineering Technology, or related field
MINIMUM RELATED EXPERIENCE
- 0-2 years of experience working in a highly regulated manufacturing environment
- Advanced MS Office (Excel, Word, Outlook, PowerPoint)
- Basic statistics knowledge, including data analysis and hypothesis testing
- Problem solving and troubleshooting
- cGMP experience
- Equipment maintenance, repair, and troubleshooting experience
- Experience with relational databases
PREFERRED RELATED EXPERIENCE
- Experience with risk evaluation tools: PFMEA, DFMEA, Hazard Analysis
- Manufacture of medical devices, biologics/biotech or pharmaceuticals
- Equipment and Process Validation knowledge
- Process Development
- Process Characterization
- Materials management
- Understanding of a QMS and working in a regulated environment
- Willing to learn and be challenged on a daily basis
Apply today for the Production Engineer position at MiraVista Diagnostics in Indianapolis. Please use the form on the website Career Center (or email your resume to firstname.lastname@example.org if you have any problems with the web form).
MiraVista Diagnostics was established in 2002 and operates a production facility and onsite clinical laboratory in Indianapolis where we process more than 100,000 diagnostic tests for serious fungal infections each year.