Senior Manufacturing Engineer- Hiring Now
This Jobot Job is hosted by: Brandon Uyeda
Are you a fit? Easy Apply now by clicking the "Apply on company site" button and sending us your resume.
Salary: $100,000 - $150,000 per year
A bit about us:
Based in Mountain View, CA We are a medical device company. Our unique patented technology leverages a low-cost small molecule sensor (SMS) array, enabling diagnostic products that simplify workflow and speed time-to-answer at low cost. Our system streamlines lab workflow, reduce costs, and substantially shorten the time from sample arrival to selection of effective therapy, saving patients faced with fast-moving and deadly drug-resistant blood infections. Our company and its founders have written almost 60 peer-reviewed publications, detailing the successful demonstration of the SMS array technology. The Company itself has independently authored over 20 scientific publications and conference abstracts detailing the SMS array powered detection, identification and antibiotic susceptibility testing.
We are looking for a Senior Manufacturing Engineer to join our growing team!
Why join us?
- Competitive Salary!
- Great Benefits Package!
- The Opportunity to Join an Amazing Team!
Job responsibilities include:
Model workflow, analyze potential automation alternatives. Evaluate potential improvements to manufacturing workflow to improve output, efficiency, lower cost and improve quality.
Specify, procure and install tooling, fixtures and equipment to establish balanced production lines.
Establish process controls, statistical measures of manufacturing performance and quality.
Establishing and modifying operational methods and processes by recommending changes in materials, equipment and procedures.
Create, execute and complete validation and qualification (IQ/OQ/PQ) documents for GMP.
Respond to manufacturing line problems to assess and repair to minimize downtime.
Support of the product and process development for new products, product changes and enhancements.
Support test methods and documentation of parts receiving including incoming inspection and managing the parts warehouse.
Support equipment maintenance and support equipment service needs.
Establish manufacturing objectives and metrics and consistently meet them
You will be a key contributor and critical to the success of the company. You should have a successful track record of scaling volume of a medical assay product while driving quality, cost reductions and output efficiency through automation, and workflow. You would be a great fit for this role if you accomplished medical assay scale at a small growing company or as a new line in a larger company.
It is important that you be comfortable and capable with the environment and responsibilities of a small, fast moving company. You will need to be hands on closely involved in all aspects of manufacturing. You should have done it before, not just managed the guy who did it. You must be a self-starter who can work effectively with others in a small high energy team focused on results and hitting deadlines. You should have the following experience and skills:
Relevant experience scaling to high volume production of medical assays.
Minimum of 7 years of experience in medical device or other regulated manufacturing environment. AS/BS in engineering or related field.
Ability to deliver under tight deadlines with a focus on quality.
Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment.
Familiarity with FDA QSR and ISO 13485 medical device regulations.
Led successful manufacture of at least two products preferably with ISO 13485 control requirements.
Strong oral and written communication and presentation skills. Effective communicator of technical & non-technical information.
Experience with managing processes and documents for GMP, ex: IQ/OQ/PQ.
Authorized to work in the United States on a full-time basis, full fluency (verbal and written) of the English language is a must.
Interested in hearing more? Easy Apply now by clicking the "Apply on company site" button.