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Supervised by: VP of Engineering & New Product Development
Summary: Designs, develops, tests and validates all aspects of mechanical, electrical, filtration components, equipment, and machinery as applicable.
Duties & Responsibilities
1. Responsible for engineering aspects of new product/process development including design, prototype, qualification, validation, product/process specification(s), manufacturing specification(s)
2. Responsible for operating within an ISO/FDA Quality System environment which includes in-depth knowledge of design controls.
3. Participation in problem-solving review, analysis, and correction(s) as required.
4. Develop methods of inspection, testing, & evaluation of developed products and competitive products.
5. Performs engineering design evaluations. May develop a range of products. Recommends alterations to development and design to improve the quality of products and/or procedures.
6. Relies on experience and judgment to plan and accomplish goals to perform a variety of tasks and maintain a customer-focused perspective in all activities initiated to ensure that company needs are successfully met.
7. Responsible for operating within an ISO13485/FDA Quality System environment which includes in-depth knowledge of design controls.
8. May devise testing procedures, evaluate and report quality & reliability of data if requested.
9. Will develop, write, and edit material for reports, manuals, briefs, proposals, instructions, and training documentation.
10. Direct, review, and approve product design and changes
11. Works with customers in field related technical issues.
12. Serves as a Technical representative to customers or manufacturing floor when needed.
13. Adhere to safety policies and procedures, and all Buffalo Filter policies and procedures, and in the employee handbook to ensure safety for self and fellow employees and to ensure behavior are appropriate in the workplace.
14. Perform other duties as assigned and requested.
Education & Qualifications:
1. Team work, good communication skills to work closely inter-departmentally
2. Light lifting
3. Bachelors degree in Mechanical engineering or technology
4. Requires good attendance and punctuality.
5. Mechanical and electrical aptitude.
6. Analytical and process oriented
7. Solidworks experience required.
8. Requires a minimum of 5 years experience within the field or related area of expertise.
9. Familiar with standard concepts, practices, and procedures to include failure mode analysis and medical device documentation.
10. +2 years Medical Device experience preferred
11. Plastics molding and sheet metal experience
12. Computer literacy a must, with technical writing and auditing skills.
13. Ability to interpret and create technical drawings.
14. PDM works experience helpful.
Work Environment & Physical Requirements
1. Work in a standard office setting using computer related equipment
2. Can work in a manufacturing facility utilizing drill presses, glue guns, jigs, assembly tools, testing equipment and fabrication equipment.
3. Most of the work is sedentary in nature; however, some walking, climbing, and lifting of product weighing up to 30 pounds may be required.
1. Work with individuals internal to the organization, including Sales and Marketing, Team Leaders, Quality, Operations and others within the organization to ensure that activities are complementary and focused on the customer.
2. Participate on company teams and committees as appropriate to ensure integration of activities.
3. Work with individuals external to the organization, including any auditors, vendors, customers or other individuals requiring specific knowledge or responsibility from an engineering and project perspective.
The above job description is not a contractual or binding document; it is provided as a guide to the types of duties required to be undertaken. Duties may vary from time to time and this description is subject to review. Modifications will be made as needed to support changes in the business climate and requirements.
As a world leader in filtration innovation, we can provide a filtration solution for every situation. From custom sizing to industry specific materials and coatings, our engineers make sure our customers are covered. We take pride in delighting our customers by providing filtration solutions for every situation.
Posted date: 25 days ago
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