19 days old

Design/Process Engineer

Kelly Services
Winter Park, FL 32789
Kelly Engineering is currently looking to hire a Design and Process Engineer to work for one of our Medical Device clients on-site in in the Orlando, FL area for a contract position. The contract is 6 months with potential for extension.

**Position Summary:**

This position is responsible for design and manufacturing process engineering responsibilities. The position may call for creation and innovation which leads to the development and introduction of new products and processes. The Design and Process Engineer may be assigned to product/process development projects, sustain and enhance existing products/processes, production troubleshooting, perform measurements, execute process validation, create engineering designs, keep laboratory notebooks on projects, and function as a member of cross functional teams.

**Major Duties and Responsibilities:**

+ Design parts of prototype systems for new products/processes.

+ Understand Design Verification and Validation

+ Perform engineering measurements and analysis.

+ Record work in a laboratory notebook.

+ Follow engineering schedules and plans.

+ Provide written reports and engineering documentation as necessary.

+ Maintain compliance with company Standard Operating Procedure and policies.

+ Participate in team decision making.

+ Demonstrate skill in the use and care of tools and equipment.

+ Demonstrate knowledge and understanding of Good Manufacturing Practices and other applicable standards.

+ Stay informed about new rules, regulations, and standards.

+ Write engineering test protocols for testing of components and integrated systems.

+ Write test reports.

+ Write and execute process validation protocols.

+ Develop and write specifications for components/systems, products, and processes.

+ Participate on or own CAPA investigations, NCMR investigations, or Customer Feedback investigations. Determine root cause and corrective or preventative actions. Implement the actions.

+ Maintain a clean, safe, and orderly work area.

+ Follow all safety procedures.

+ Perform other duties and responsibilities as required.

+ The Design and Process/Manufacturing Engineer may be supervised while performing any and/or all of the following duties by either the Director of Engineering or the Director of QA Compliance

**Principal Working Relationships:**

+ Works with other engineering personnel to develop engineering prototypes of new products/processes.

+ Works with engineering personnel on production problems and changes.

+ Works with cross-functional teams to define and introduce new products.

+ Works as a team member in the development of engineering design and tests.

**Required knowledge and abilities:**

+ Skills in Microsoft Office Suite and various engineering CAD tools.

+ Ability to carry out engineering calculations and analysis.

+ Ability to write engineering documents, test protocols, laboratory notebook entries, and test reports.

+ Ability to perform component engineering design and changes.

+ Ability to operate light machine tools and laboratory equipment.

+ Ability to interpret displayed results on laboratory equipment.

+ Ability to communicate effectively with internal and external personnel.

+ Effective oral and written communication skills.

+ Knowledge of change order system.

+ Knowledge of engineering documentation.

+ Knowledge of ISO 13485 and FDA 21 CFR Part 820

+ Must be able to operate a variety of automated office machines including computers, copiers, printers, facsimile machines, telephone, etc.

**Physical Requirements (including but not limited to):**

+ Work hours 8 am to 5 pm, with a one 1 hour lunch

+ Sitting many of the working hours using a computer and mouse

+ Wearing headset for Skype conversations while looking at computer monitor and using keyboard and mouse.

+ Using hands to work with devices while sitting or standing.

+ Using hands to manipulate small parts while sitting or standing.

+ Travel to Vendor/Supplier locations independently.

+ Minimal lifting up to 50 pounds.

+ Exposure to cleaning chemicals.

**Minimum Education, Training, and/or Experience.**

+ B. S. degree in Mechanical Engineering (or a related field with adequate experience) or 2 5 years experience in engineering practice, including project development responsibility in the medical device industry.

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-11-13 Expires: 2020-12-14

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Design/Process Engineer

Kelly Services
Winter Park, FL 32789

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