Job Details

ID #45620394
State California
City San diego
Full-time
Salary USD TBD TBD
Source Thermo Fisher Scientific
Showed 2022-09-11
Date 2022-09-12
Deadline 2022-11-10
Category Et cetera
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Engineer I, Mechanical

California, San diego, 92101 San diego USA

Vacancy expired!

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.SUMMARY:This position will be responsible for support of ongoing 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 proven experience, proficiency in Solid Works 3D Design, and experience working under FDA QSR/ISO 13485 environment.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.

Involved with the engineering team for identifying the most effective production process and guidelines.

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

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

Prepares product and process reports by collecting, analyzing, and summarizing information and trends.

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

Provides manufacturing engineering information by answering questions and requests.

Completes design and development projects by training and guiding technicians.

Chips in 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

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

KNOWLEDGE AND SKILLS:At least 1 to 3 years' of proven 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 working with lyophilized reagents is desirable.

Proficient with Solid Works 3D design.

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

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

Previous Manufacturing Engineering experience and cGMP and/or CLIA laboratory experience.

Able to take care of complexity manufacturing processes,

Skilled in Manufacturing Quality and Product Development

Able to present technical information in an understandable format

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 interpersonal skills and work well in a fast-paced, start-up environment

High level problem solving, and reasoning skills required

Experience with statistics, Statistical Process Control and DOE techniques is desirable

Good solid understanding of manufacturing equipment.

Ability to resolve issues quickly and recommend preventive solutions

Solid understanding of statistical analysis

Strong GMP and GDP knowledge

Knowledge of MS office suite

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

Lean/Six Sigma experience preferred

EDUCATION/EXPERIENCE REQUIRED:A minimum of a BS in Mechanical Engineering, Industrial Technology, or other relevant Engineering subject area.

1 to 3 years’ experience working in FDA and ISO 13485 regulated company

Solid understanding of 13485:2016

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

Product manufacturing, inspection, and testing experience is desirable.

PHYSICAL DEMANDS:While performing the duties of this job, is regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, or wear safety gear. Must regularly lift and / or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds.

Excellent verbal and written documentation skills in English

Available nights, weekends, and holidays when needed

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific). As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, tackle sophisticated scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Vacancy expired!

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