Job Title: Manufacturing Engineer

Job Category: Exempt

Department/Group: Operations

Reports: Commercial Operations Manager

Location: Campbell, CA

Travel Required: Yes

Position Type: Full-time

JOB DESCRIPTION:

The Manufacturing Engineer is primarily responsible for supporting the Commercial Operations Manager with the opportunity to work on a variety of engineering assignments utilizing a wide-range of engineering principals.  This position works on product and process development activities varying from concept generation to product testing and data collection and validation.

DUTIES:

  • Contribute to design, prototyping and testing activities, and assist engineers as needed.
  • Hands-on work in R & D Lab and help in the assembly, development and documentation of ZipLine products.
  • Assist with evaluation and/or design of materials, equipment, fixtures, automation, and processes.
  • Assist engineers in the planning, development and design of processes and equipment for the manufacture of ZipLine products.
  • Work from schematics, diagrams, written and verbal descriptions, layouts or defined plans to perform testing, evaluation and trouble-shooting functions.
  • Work with engineers to provide ideas and suggestions for improved design concepts and qualification activities.
  • Other duties as required.

QUALIFICATIONS:

B.S. in Mechanical Engineering, Bioengineering, Industrial Engineering or equivalent practical experience.

  • Must be detail oriented, dependable and possess excellent written and verbal communication skills.
  • Strong organizational, problem-solving, and analytical skills; able to manage priorities and workflow.
  • Versatility, flexibility, and a willingness to work within constantly changing priorities.
  • Ability to prioritize, manage time well, multitask and troubleshoot.
  • Able to work in a regulated environment in accordance with internal operating procedures and external standards and regulations.
  • Must be able to work independently and able to work in a fast-paced and deadline driven environment
  • Must be computer savvy and well-versed in Microsoft Office products and Solidworks.

Must follow company policies and procedures, GMP, ISO, and FDA regulations.

Please send your resume and information to careers@ziplinemedical.com

Job Title: Quality Engineer

Job Category: Exempt

Department/Group: Quality and Regulatory Affairs

Reports: Director of Quality & Regulatory Affairs

Location: Campbell, CA

Travel Required: Yes

Position Type: Full-time

JOB DESCRIPTION:

The Quality Engineer is responsible for managing company controlled documents, records and training, as well as ensuring their completion, accuracy and quality.  This includes adherence to procedural requirements, record retention policies and good documentation practices.

The Quality Engineer is also responsible for providing Operations support by performing inspection activities for components and finished devices, coordinating calibration activities, and working with suppliers for documentation issues.

DUTIES:

  • Implement and maintain company Quality Systems. Perform CAPA and Complaint investigations. Provide engineering support to R&D and Operations activities.
  • Perform Document Control duties for managing all aspects of company controlled documents and training records. This includes document storage, retention, retrieval, destruction, and tracking the status of document change orders according to the company’s document lifecycle procedures.
  • Interface with the Contract Manufacturer for document changes, requests for Certifications, device history records, and other quality documentation
  • Preparation and maintenance of Employee Training Sets and training curriculum, including notification of training requirements and monitoring of training status
  • Perform incoming inspection of components used in manufacturing and inspection of finished device for final acceptance and generate nonconforming material reports, as needed
  • Coordinate calibration activities for measuring and test equipment with the calibration supplier, including review of calibration results and initiating and tracking of out of tolerance equipment
  • Interface with suppliers when there are documentation issues, requests for information, etc.
  • Assist with trend analysis, filing, audits, and perform administrative tasks as needed.
  • Other duties as required

QUALIFICATIONS:

  • Ability to prioritize, manage time well, multitask and troubleshoot
  • Must be able to work independently and able to work in a fast-paced and deadline driven environment
  • Must be detail oriented, dependable and possess excellent written and verbal communication skills
  • Follows company policies and procedures, GMP ISO, and FDA regulations.
  • Must be able to read and interpret drawings and specifications
  • Must be able to use a wide variety of inspection tools, including rulers, calipers, micrometers, pin gauges, and tensile testing equipment. Ability to use an optical comparator or vision system highly desirable.
  • Must be able to understand basic metrology requirements and interpret results from calibration reports

Education – BS in engineering or equivalent experience preferred.

Please send your resume and information to careers@ziplinemedical.com

Founded in 2007 in Silicon Valley, CA, ZipLine Medical is a medical device company pioneering advanced wound closure and surgical recovery technology to provide surgeons with solutions that provide superior economic, clinical and patient-friendly alternatives to the status quo. Our employees and their dedication to advancing these technologies is what sets us apart from other medical technology companies.

Please send your resume and information to careers@ziplinemedical.com