Senior Manufacturing Process Engineer
2 weeks ago
Position Overview:
The Senior Manufacturing Process Engineer plays a pivotal role within a collaborative Manufacturing Engineering team, focusing on various elements of the consumable production process. This position involves close collaboration with internal stakeholders and external suppliers to enhance product efficiency. Responsibilities include diagnosing issues and performing routine upkeep on both manual and automated manufacturing systems.
Utilizing extensive expertise, this engineer will implement optimal practices in the domain of consumable medical device production by pinpointing underlying issues and proposing effective solutions.
This role contributes significantly to addressing moderate to complex challenges in manufacturing engineering.Key Responsibilities:
- Ensure compliance with company policies and adhere to BioFire Diagnostics' Quality System standards.
- Support various aspects of biochemical reagent, formulation, and consumable product manufacturing.
- Guide and mentor junior engineers in their development.
- Collaborate with suppliers to enhance product performance.
- Gather and evaluate data to assess product effectiveness.
- Foster relationships internally and externally as part of a cross-functional team.
- Conduct troubleshooting and routine maintenance on manufacturing equipment.
- Assist in Non-Conformance Report (NCR) investigations, documentation, and product evaluations.
- Implement best practices and corrective measures.
- Identify previously unrecognized process variables and establish optimal practices.
- Conduct Failure Mode and Effects Analysis (FMEA) to uncover root causes and suggest potential solutions.
- Contribute to resolving moderate to complex manufacturing engineering and biochemistry production challenges.
- Make design and technical decisions, subject to review by the Manufacturing Engineering Manager.
- Create a variety of technical documentation, including Work Instruction Documents (WIDs), technical assessments, studies, and executive summaries.
- Perform primary duties in a controlled clean room environment.
- Develop and execute validation processes for new equipment and procedures in accordance with FDA regulations. Other duties as assigned.
Travel Requirements:
Some travel may be necessary.
Team Dynamics:
Typically collaborates with a team comprising several technicians, engineers, and a project manager.
Experience Requirements:
A minimum of 3 years in Engineering or a related field, demonstrating consistent performance, or 2 years with a master's degree in Engineering, Bioengineering, Chemistry, Life Science, or a related discipline.
Essential Skills:
Support in Manufacturing Engineering, Reagent Production, Quality Assurance, Process Control, and Equipment Management:
- Failure investigation and analysis
- Troubleshooting and repair of production machinery and instrumentation
- Technical documentation and writing
- Inspection and quality control
- Process validation
- Familiarity with FDA regulations
- Nucleic acid chemistry knowledge
Preferred Experience:
- Geometric Dimensioning and Tolerancing (GD&T); Statistical Process Control (SPC)
- Film and plastic bonding and sealing techniques
- SolidWorks proficiency
- Sheet metal design capabilities
- Material science knowledge (e.g., plastics, aluminum, copper, steel)
- Pneumatics and machining experience (especially CNC)
Highly Preferred Experience:
- Troubleshooting and repair of reagent production equipment and instrumentation utilized in oligonucleotide synthesis and PCR chemistries (e.g., liquid handling robots, PLCs, LCMSs, oligo synthesizers, lyophilizers, labelers, and tube and plate sealers)
- Nucleic acid purification and characterization expertise
Physical Requirements:
Ability to safely lift up to 50 pounds.
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