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Aerotek Manufacturing Engineer in San Diego, California

SUMMARY :

This position will be responsible for support of on-going commercial production activities by providing technical leadership to optimize, improve and upgrade our manufacturing processes. Lead process sustaining, definition and improvement, design, development, and quality test activities in the making of our products or support of processes/equipment. Additionally, be responsible for the design, validation, and implementation of automation, fixtures, and

processes needed for the production manufacture of point-of-care, in-vitro diagnostic instruments and disposable test cassettes. This position requires relevant experience, proficiency in Solid Works 3D Design, and experience working under FDA QSR/ISO 13485 environment.

Shift :

4x3, 3x4

12-hour shifts (work every other Wednesday)

  • Sunday – Tuesday (6:00 am – 6:00 pm)

  • Sunday – Tuesday (6:00 pm – 6:00 am)

  • Thursday – Saturday (6:00 am – 6:00 pm)

  • Thursday – Saturday (6:00 pm – 6:00 am)

RESPONSIBILITIES:

  • Assist in the evaluation of the manufacturing processes by designing and conducting research; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators

  • Involvement with the engineering team for identifying the most effective production process and guidelines

  • Develop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors

  • Assist in Improving manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout

  • Assure product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes

  • Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements

  • Prepare product and process reports by collecting, analyzing, and summarizing information and trends

  • Be assigned with various other tasks that need to be completed along with the Engineering projects

  • Provide manufacturing engineering information by answering questions and requests

  • Keep equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service

  • Complete design and development projects by training and guiding technicians

  • Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

  • Contributes to team effort by accomplishing related results as needed

· Implementation and integration of automation systems

· Production scale-up from manual, to semi-automated and fully automated solutions

· Design verification and validation per ISO 13485

KNOWLEDGE AND SKILL:

· At least 10 years of experience in the development and/or manufacture of IVD/Medical devices

· Experience with programmable logic controllers

· Experience with machine vision systems

· Experience in the integration of automated production systems

· Experience in ultrasonic welding

· Experience working with lyophilized reagents

· Prior experience working under FDA QSR / ISO 13485 regulated environment

· Experience with 6 sigma, lean manufacturing, and 5S a plus

· Able to deal with complexity manufacturing processes

· Proficient at Manufacturing Methods and Procedures

· Skilled in Manufacturing Quality and Product Development

· Able to present technical information in an understandable format

· Hands on experience in: CAD, CAD/CAM design

  • Ability to work in a multidisciplinary team environment, to multi-task, to handle frequently changing job functions and to rapidly learn new techniques and approaches

  • Must have good communication skills and work well in a fast-paced, start-up environment

· Good working knowledge of manufacturing equipment

· Ability to resolve issues quickly and recommend preventive solutions

· Strong knowledge of statistical analysis

· Strong GMP and GDP knowledge

· Knowledge of MS office suite

· Design of Experiments (e.g. JMP or equivalent)

· Lean/Six Sigma experience

EDUCATION/EXPERIENCE REQUIRED:

· BS in Mechanical Engineering, Industrial Technology, or other relevant Engineering discipline

· 10 years’ experience working in FDA and ISO 13485 regulated company

· Working knowledge of 13485:2016

· 10 years previous Manufacturing Engineering experience and cGMP and/or CLIA laboratory experience

· 10 years’ experience in biotech / IVD / Medical Device

· Experience with medical device manufacturing processes qualification (IQ/OQ/PQ)

· Product manufacturing, inspection, and testing experience

· All development activities will meet or exceed ISO 13485 design control and risk assessment requirements

· High level problem solving, and reasoning skills

· Experience with product development processes and project management skills

· Experience in production support and/or process development

· Experience with statistics, Statistical Process Control and DOE techniques

PHYSICAL DEMANDS:

· Good written and verbal communication skills

  • Ability to work long hours and execute under pressure with short turnaround times

  • Ability to speak, write, and use all office equipment including scanner and printer, phone, computer, etc.

  • Available nights, weekends, and holidays when needed

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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