OrthoAccel® Technologies, Inc. is a privately owned medical device company engaged in the creation, manufacturing, marketing and sales of innovative solutions that enhance dental care and orthodontic treatment. Among the company’s innovations is AcceleDent, an FDA-cleared, Class II medical device that speeds up orthodontic treatment by as much as 50 percent. OrthoAccel, the LEADER IN ACCELERATED ORTHODONTICS®, has received positive feedback from patients and leading orthodontists from around the world who recommend the award-winning AcceleDent as the fast, safe and gentle solution to accelerate orthodontic treatment. Ranked on Deloitte’s Technology Fast 500 as one of the fastest growing companies in North America, OrthoAccel is based in Houston, Texas and operates globally in over 40 countries with more than110 employees. To learn more about OrthoAccel’s focus on improving the journey to healthy, beautiful smiles, visit AcceleDent.com.
The Manufacturing Engineer (ME) will support and lead numerous cross-functional projects primarily in the Operations and Engineering departments, from new and sustaining engineering development projects to internal process improvement efforts.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- New product development such as part design, qualifying new injection molders, contract manufacturers, process equipment, tooling design and development as well as sustaining engineering
- Lead the finalization of the mechanical design for new products while collaborating with external design firms and marketing
- Establish processes at contract manufacturer(s), participate in usability studies, create and review engineering and regulatory documentation and all activities required to bring the new design to volume production
- Ability to document requirements, design, development, test, IOQ/PQ equipment, and document the entire process.
- Address complaints, corrective actions, complete root cause analysis, documentation, implementation of solutions, process changes, cost reduction, and lean manufacturing, among others
- Verification, validation, and /or qualification testing for the product and process for both new designs and modified designs
- Interact with several teams within Operations and Quality as well as Marketing, Innovations Team, IT, Finance, Sales, Supply Chain, and at times, the Executives
- Work with IP attorneys to review and provide feedback on new IP being presented on behalf of the company
- Quick study on FDA regulations, medical device ISO standards, and company procedures and process
- Drive portion of projects independently as well as show leadership and subject matter expertise when it comes to design, process, and equipment design and development, while working cohesively with team
MINIMUM REQUIREMENTS AND QUALIFICATIONS
- BS Mechanical Engineering Degree or related field
- 5+ years’ of experience
- 3+ years’ experience with new product development
- Small consumer electromechanical devices or medical devices experience
- Plastics selection, processing, material, color, finish experience
- Custom process equipment and tooling design, development, and documentation
- Extensive experience with SolidWorks required
- Demonstrated proficiency in tolerance analysis
- Previous experience working directly with suppliers and design firms
- Ability to understand, investigate, and learn about new topics relatively quickly
- Ability to work with and support a team internally and through contract design and manufacturing companies
- Demonstrated experience with meeting or beating cost targets
- Previous experience with design qualification (verification and validation) testing
- Demonstrated ability to lead projects from concept through release in a regulated industry
DESIRED SKILLS AND QUALIFICATIONS
- Previous experience working with Good Manufacturing Practices (GMP), ISO standards, and Lean Manufacturing
- MS degree
- Fluent in Thai
- Previous experience with process development and process equipment
- Previous experience with packaging design and testing
- Ability to search and select new suppliers using the RFP and RFQ process
- FDA Quality Management System Experience (Medical Device experience)
- Experience in Design, Development and Manufacturing Processes of Consumer Electronic Products
- Strong interest in Industrial Design
- Must be self-motivated and a self-starter
- Extremely detail oriented
- Effective organization, prioritization, analytical, communication, and interpersonal skills
- Excellent verbal, written, problem solving, data analysis skills
- Ability to work in a fast paced, small company environment
- Exceptional documentation skills
Low travel requirement – typically 25% or less over the year. Travel will include domestic and international travel.
Interested candidates are invited to submit their resumes and cover letters to: email@example.com with salary requirements. Kindly include the position for which you are applying in the subject line. Due to the volume of resumes we receive, only qualified candidates will be contacted. No calls, please.
Thank you for your interest in OrthoAccel Technologies, Inc.