Senior Manufacturing Engineer at Truvian Sciences, Inc. in San Diego, CA

JOB SUMMARY

Truvian is seeking a talented and experienced Sr. Manufacturing Engineer to join the Technical Operations team. Candidates demonstrating increasing responsibility and direct experience in consumables manufacturing within the life sciences industry will be considered.

The scope of the role includes, but is not limited to, the hands-on design, modification, characterization, and ultimate qualification of production processing equipment as well as sustaining the supporting processes as we scale. The primary consumables include an injection molded disc, reagent cartridge, and microfluidic sub-system with various process steps required in order to make the final consumable kit.

The individual filling this role will work closely with consumable design engineers, automation design engineers, production technicians and operators, and other members of the broad organization. The candidate must be a strong and clear communicator as presenting concepts, strategy, experiments, and results to management and top leadership is required.

Since equipment qualification and process validation is a top responsibility of this position, strong attention to detail and clear and concise documentation – protocol preparation and execution – is required.

HERE’S WHY YOU’LL LOVE THIS JOB:

You'll work with a rock star team of people who are passionate about the work they do and our ability to disrupt healthcare with our innovative products

You’ll be a key player on a team responsible for the company’s growth and product launch

You thrive in a fast-paced and dynamic environment where you can implement fresh ideas, new processes, and make things happen quickly without a bunch of red tape

You’ll have great perks such as: Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K), flexible PTO, Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks, on site gym and virtual classes, and a farm to table onsite restaurant including a 30% discount

WHAT YOU WILL DO:

Build, develop, and implement manufacturing processes, light to medium automation equipment, and manual fixtures to facilitate controlled production of consumables which meet Truvian's QMS requirements

With minimal guidance generate Equipment Qualification (IQ/OQ/PQ) and Process Validation (PV) protocols, perform execution and reporting, to ultimately qualify the manufacturing processes in preparation for FDA filing

Develop, implement, and sustain manual, semi-auto, and fully automated production processes and workstations to maximize output and control quality

Construct, execute, and evaluate controlled experiments (including DOE's) to optimize processes, address yield and quality issues, and drive implementation of solutions into a production environment

Perform root cause analysis and implement quality control solutions to sustain and support production as issues arise

WHAT YOU WILL BRING:

The candidate must have a minimum of 8 years experience in Manufacturing (or Process) Engineering ideally in the Operations side of the company.

Other requirements as stated below:

Bachelor's Degree in Engineering (Mechanical, Industrial, Biomedical, Chemical or Related Field)

Direct experience in Equipment Qualification (IQ/OQ/PQ) in an FDA Class II/III industry

Direct experience in a GMP/ISO 13485 regulated manufacturing environment