Manufacturing Engineer

2 days ago


Santa Clara, California, United States inSync Staffing Full time

3 Month+ possible contract to direct hire

  • Proactively support company goals and objectives, policies and procedures, Ancora Quality System, regulations, and regulatory requirements. employees must demonstrate commitment to providing our customers with high quality medical devices.

PURPOSE OF JOB

  • Support the company's transition from clinical stage to commercialization within product design and improvements for manufacturability. Work closely with the R&D, Operations, and Quality Systems staff to improve existing processes and perform process validations. This hands-on role requires accountability and the ability to work with minimal supervision. This is an on-site position.

MAJOR DUTIES AND RESPONSIBILITIES

The successful candidate will participate in:

  • Updates to product designs as-needed to support high volume manufacturing
  • DV tests, fatigue testing, and reports
  • Design, documentation, assembly, and qualification of product assembly / test / inspection fixtures and equipment
  • Specification, procurement and implementation of off the shelf automated and semi-automated equipment
  • Validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ)
  • Maintenance of manufacturing documentation including material and component specifications, work instructions, BOMs, routers, Process FMEAs, DMR, protocols, reports, and DHF documents
  • Training operators on new processes, tools, and equipment.
  • Developing testing methods; testing sub-assemblies, finished product and process capabilities
  • Develop, qualify and implement processes to improve manufacturability
  • Complete projects and tasks in a timely manner consistent with corporate objectives
  • Support company goals and objectives, policies and procedures
  • Perform other duties as assigned

QUALIFICATIONS

EDUCATION REQUIREMENTS:

  • Minimum B.S. in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or similar Engineering discipline.

EXPERIENCE REQUIREMENTS:

  • Minimum 3 years of related experience

REQUIRED SKILLS:

  • Experience with SolidWorks
  • Ability to work in a CER ISO 7 environment, engage with medical device assemblers to learn and understand current manufacturing challenges.
  • Strong background in test methods, protocol and report writing
  • Flexibility to perform a wide range of activities in parallel.
  • Strong communication skills, sound judgement
  • Willingness and ability to work independently and in teams
  • Microsoft Office products, including Excel, Word, and PowerPoint.

DESIRED SKILLS:

  • Experience with analytical tools such as Mini-Tab, MatLab
  • NiTi components, SN testing and fatigue testing desired.
  • Knowledge of FDA, QSR and MDR regulations and relevant FDA Guidance and ISO standards.
  • QSR
  • DOE
  • IQ/OQ/PQ
  • SPC
  • Strong background in DFMEA, SHA, quality inspection methodology
  • PLC programming, operation

Benefits (employee contribution):

  • Health insurance
  • Health savings account
  • Dental insurance
  • Vision insurance
  • Flexible spending accounts
  • Life insurance
  • Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act



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