Based in Houston, Texas, OrthoAccel® Technologies, Inc. is a privately owned medical device company currently engaged in the development, manufacturing, and marketing of products to enhance dental care and orthodontic treatment.
OrthoAccel® developed and sells AcceleDent® Aura, the first FDA-cleared clinical approach to safely accelerate orthodontic tooth movement by applying gentle micropulses (SoftPulse Technology™) as a complement to existing orthodontic treatment. More information can be found at acceledent.com and acceledent.co.uk or requested via email@example.com.
The Mechanical 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
• 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
• Injection molding experience (small consumer electromechanical devices or medical devices)
• Plastics selection, processing, material, color, finish experience
• Extensive experience with SolidWorks required
• Demonstrated proficiency in tolerance analysis
• Previous experience with process development and process equipment
• Previous experience with packaging design and testing
• 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
• Ability to search and select new suppliers using the RFP and RFQ process
• 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
• 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 15% or less over the year. Travel will include domestic and international travel.
Dependent on Experience
Interested candidates are invited to submit their resumes and cover letters to: firstname.lastname@example.org 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.