Process Engineer

MTF Biologics processes tissue grafts from human donors that are used in a growing array of clinical applications – positively affecting lives across the globe. As a global nonprofit organization that saves and heals lives by honoring donated gifts and serving patients, we collaborate with the medical, scientific, as well as organ and tissue donation communities.

Our goal is simple–do what's right for patients, surgeons, tissue donors, and their families through our guiding principles.

Primarily responsible for technical expertise and support for daily processing operations and process improvement projects in either Jessup and/or Edison facilities. Ensure that safety, quality and yield targets are met. Perform Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) on processing equipment. Work with cross-functional teams to provide solutions to processing issues in the core. Work independently on Corrective and Preventive Action (CAPA) project teams and Nonconformances (NCR's) related to processing deviations. Direct and plan engineering projects or studies.

1. Develop and execute validation protocols (IQ/OQ/PQ) to assess process capability, analyze data using statistics, and generate required compliance documentation.
2. Investigate, integrate and evaluate the impact of new process introductions.
3. Assess and implement process changes as required by internal or external customer request, in response to processing quality issues, or design changes.
4. Participate in process risk analysis activities (FMEA) to support new or existing processes.
5. Implement change controls and ensure processing documents/procedures/specifications are complete, accurate, and current.
6. Perform investigations and root cause analysis for NCR’s. Implement corrective actions.
7. Participate in processing investigations/CAPA/complaint resolutions to identify process improvements.
8. Develop and deliver new manufacturing process capabilities as needed including process selection, characterization, and qualification utilizing design of experiments (DOE) methodology.
9. Support evaluation of new device designs for manufacturability (DFM/DFA).
10. Responsible to answer technical questions from marketing, processing technicians, etc. as requested.
11. Responsible to resolve immediate safety concerns on core equipment.
12. Responsible to facilitate all aspects of process development from feasibility testing to process automation.
13. Develop functional gages and create quality inspection procedures to streamline inspection process.
14. Program and troubleshoot processing equipment (e.g. CNC, PLCs, HMIs, mechanical and pneumatic systems).
15. Responsible for cost reduction and quality improvement projects.
16. Train technicians and facilitate technician training as required.
17. Enter clean room periodically to qualify and audit processes.
18. Work with R&D to develop and implement new high precision machining processes including build prototypes, design fixtures/tools, and perform process capability studies.
19. Provide oral and written project updates to individuals and groups as necessary.
20. Responsible to discover, investigate and integrate new technologies into the processing area.
21. Responsible to transfer new grafts and devices into manufacturing. Utilize project management and planning techniques to lead a team through seamless transition from R&D or Project Engineer to Processing.
22. Team member on special projects and perform additional duties as assigned.

MINIMUM QUALIFICATIONS

Education:  Bachelor's Degree in Engineering Discipline

Years of Experience:  3 - 5 years

                                    Other:   Minimum 3 years of experience in a manufacturing environment. 

Specific Licenses and/or Certifications:   Other

                                    Other:   N/A

Specialized Knowledge, Technical Skills, and Abilities:

• Critical thinking
• Basic statistics
• Ability to work independently and with a team
• Proficiency in Microsoft Office and Project
• Experience in medical device manufacturing or a GMP environment helpful.
• Customer/vendor interaction and strong communication skills.

PREFERRED QUALIFICATIONS

Education:  Bachelor's Degree in Engineering Discipline

Years of Experience:  3 - 7 years

                                    Other:   N/A

Specific Licenses and/or Certifications:   Other

                                    Other:   N/A

Specialized Knowledge, Technical Skills, and Abilities:

• Proficiency in CAD/CAM. Solid modeling preferred.

For Trinity: Experience in cryogenic preservation technologies