Location: San Diego
Posted on: June 25, 2022
AboutTruvian is a healthcare company at the intersection of
diagnostics and consumer tech. We are disrupting the blood testing
industry by developing an automated, benchtop diagnostic system to
provide lab-accurate results in 20 minutes for a comprehensive
suite of health tests. Our proprietary approach, for which we are
seeking FDA clearance, is intended to fulfill the promise of
delivering accessible and affordable blood testing from one small
blood sample, in minutes, in a retail setting or private
clinic.Truvian has also expanded our focus to address the surge in
demand for antibody tests by introducing Easy Check COVID-19
IgM/IgG antibody test. This test will create higher standards of
performance, speed, and scalability for the rapid detection of
IgM/IgG antibodies to SARS-CoV-2.Job SummaryWe are looking for a
talented Lean Manufacturing/Production Manager (depending on
qualifications) to become a member of the Operations team at
Truvian Sciences, reporting to the Director, Operations. Candidates
with a proven track record of leading production teams in a
GMP/ISO-13485 environment will be considered for the role. The
scope of the work will include, but is not limited to, providing
daily supervision of Production Operators, coordinating activities
to meet the forecasted demand of consumables, training and
developing production operators, compiling, and presenting
production metrics, and helping to create/update manufacturing work
instructions. As needed, the Production Supervisor/Manager may be
required to perform consumables production alongside the Production
Operators. This individual must be a strong communicator, as
understanding and interpreting detailed instructions, along with
the ability to relay those instructions to others both verbally and
in writing, is a key element of this role. A background in GMP
manufacturing and ISO-13485 environments is highly preferred.If you
want to stand out, please include a cover
- Ensures the production schedule is adhered to and supported in
terms of staffing, work schedules, planning activities, and
- Ensures cGMP guidelines, SOPs and Safety Guidelines are
followed at all times.
- Drive continuous improvement activities using lean mfg.
principles & tools.
- Writes new, amends current, and trains personnel on SOPs that
accurately cover all activities within the department
- Perform investigations for Deviation Reports accurately and
- Prepare production documents, such as standard operating
procedures, manufacturing batch records, inventory reports, or
- Manages production team on assembly and filling lines a manner
that optimizes customer service and operation efficiency.
- Tracks and reports production metrics and troubleshoots issues
related to the execution of the production schedule.
- Effectively able to communicate status of essential duties and
responsibilities with different levels of the department.
- Participates in company or department sponsored process
improvement teams such as continuous improvement, variance
reduction, training and development, and others.
- Hires, trains, evaluates, promotes, and disciplines
- Assists, as needed, to prepare and assemble materials, build
product subassemblies or final assemblies
- Present department status, improvement plans, and strategies to
- Other duties to be assignedQualifications And Skills
- A minimum of 5 years of cGMP, ISO 13485 industry
- Must have minimum of 3 years as a Manufacturing Supervisor
position in the medical device/biotech industry.
- A minimum of 1 year of production manager experience.
- 2+ years of Lean Manufacturing deployment experience.
- Lean Certification and Six Sigma Certification (Green Belt,
Black Belt) is preferred.
- Technical writing skills, Project management skills.
- Experience in a start-up and/or pilot production
- Excellent written and verbal English communication skills
- Mechanical aptitude with thorough knowledge of product
assembly, fluid dispensing, and automated systems.
- Intermediate level of Computer Skills - Excel, Word,
- Prior experience in medical device or IVD product development
- Very strong analytical and problem-solving skills; organized
- Proven interpersonal, communication, and presentation skills;
excellent time management skills
- Able to excel in collaborative, fast-paced, and evolving start
up environment; able to manage competing priorities
- Superb attention to detail; produces work of exceptional
quality and accuracy.
- Ability to proactively identify issues and address with
- Bachelor's degree, preferably in a technical field
- YesPhysical Demands And Abilities
- Regularly required to use hands to finger, handle or feel,
reach with hands and arms and talk or hear
- Ability to lift and move over 25 lbs. repeatedly and safely,
occasionally 75 lbs. with assistance
- Frequently required to stand, walk, stoop, kneel, crouch or
- Occasionally required to sit and climb or balance
- Specific vision abilities required for this job include close
vision, distance vision, color vision, peripheral vision, depth
perception and ability to adjust and focus. What We Offer
- Generous Benefits (Medical/Dental/Vision/EAP/Paid Life
- Flexible PTO
- Kombucha on Tap
- Variety of healthy snacks
- Craft Coffee
- Cold Brew on Tap
- On Site Gym and Virtual Classes
- On Site Restaurant - with a 30% discount Truvian provides equal
employment opportunities to all employees and applicants for
employment and prohibits discrimination and harassment of any type
without regard to race, color, religion, age, sex, national origin,
disability status, genetics, protected veteran status, sexual
orientation, gender identity or expression, or any other
characteristic protected by federal, state, or local laws.This
policy applies to all terms and conditions of employment, including
recruiting, hiring, placement, promotion, termination, layoff,
recall, transfer, leaves of absence, compensation, and
Keywords: Truvian, San Diego , Manager, Production, Professions , San Diego, California
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