Job Title:
Product Development Director
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Key Job Responsibilities
As a Product Development Director, you will lead higher-level engineering efforts to design and develop new medical devices, manufacturing processes, equipment, and systems by defining specifications, materials, and manufacturing procedures.
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Key Performance Indicators
* Support new product development by leading technical assessments of new product design inputs, collaborating closely with cross-functional teams, and delivering high-quality solutions that meet user needs.
* Translate multiple inputs from regulatory, quality, marketing, human factors, etc., into product requirements, specifications, and detailed trace matrices.
* Interface with marketing, healthcare professionals, customers, and suppliers as necessary to identify product opportunities, develop product solutions, solve problems, and complete projects leading up to commercialization of new or modified products.
* Provide appropriate direction or directly lead higher-level engineering efforts to design products, processes, equipment, tooling, and components using engineering principles on computer-aided design (CAD) systems and evaluating them using analysis techniques such as finite element analysis (FEA).
* Perform product testing, create models and prototypes to prove out new designs and changes to existing designs.
* Lead higher-level engineering development projects as assigned, including problem-solving projects to resolve issues in manufacturing or product performance. Provide uniform solutions for international manufacturing operations.
* Champion continuous improvement of manufacturing processes and equipment through the use of lean manufacturing and statistical data analysis techniques such as total material value (TMV), gage studies, process capability studies, design of experiments (DOE), and statistical process control (SPC).
* Lead or participate in project, design, and technical reviews.
* Interview, recommend, and assist in the selection of department personnel, including engineers and summer interns.
* Troubleshoot and coordinate improvements to existing products, manufacturing processes, machine test equipment.
* Support regulatory submissions and clinical trials as required.
* Ensure projects are developed and documented in compliance with the quality management system.
* Develop, approve, and revise quality system documents, including standard operating procedures (SOPs), work instructions, and validation protocols and reports.
* Adhere to and ensure compliance with company policies, quality management system (QMS) procedures, and housekeeping standards.
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Required Skills and Qualifications
* Bachelor of Science in mechanical or biomedical engineering, professional engineer certification, or advanced degree preferred; other technical disciplines considered.
* 6 or more years of relevant experience in an engineering field related to manufacturing.
* Strong analytical, technical, and problem-solving skills.
* Hands-on experience preferred.
* Effective verbal and written communication skills.
* Team player with good interpersonal skills.
* Proficient in Microsoft Office Suite, SolidWorks, or equivalent modeling systems, statistical analysis, and computerized analysis applications.
* Self-motivated, high-energy, positive attitude individual with the initiative and drive for timely completion of goals.
* Excellent multi-tasking, analytical, communication, and prioritization skills.
* Ability to work independently with minimal supervision as well as in a team environment.
* Excellent communicator with ability to run meetings and workshops.
* Able to travel domestically and internationally.
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Benefits
Competitive salary, comprehensive benefits package, and opportunities for career growth and development.
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How to Apply
For further information, please contact [Name] at [Phone Number].