Job Description
Support development of products and/or product engineering for medical device with work including writing or verifying specifications; designing new products and fixtures; testing processes and equipment; and specifying raw materials to ensure the concepts and/or prototypes meet their requirements. Job duties:
Develop new product concepts and products by applying various engineering disciplines, such as mechanical, electrical, materials, bioengineering, or other relevant fields.
Provide engineering design and process development, and/or sustain engineering support.
Develop products or processes, or the capabilities to support them, such as test methods, equipment/fixtures, data engineering, statistics, software coding and application, engineering/business intelligence, or various analytical methods, etc.
Generate intellectual property; write invention disclosures.
Largely self-directed and capable of meeting project goals with minimal supervision.
Lead projects and may supervise Technicians, Assemblers, and others as needed.
Some travel required.
Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
Perform additional duties related to business objectives as needed.
Qualifications
Bachelor's degree in Engineering or Scientific field.
A minimum of four (4) years of relevant work experience.
Strong written and verbal communication skills.
Proficient computer skills including MS Word, Excel, Outlook, Teams, and CAD (SolidWorks or PRO/E proficiency required).
Desired Qualifications
Advanced degree in Engineering or Scientific field.
Design and development of medical devices and working knowledge of cGMP.
Ability to read and prepare technical documentation.
Working knowledge of standard machine shop equipment, processes, and medical device manufacturing equipment.
Knowledge of medical and technical development as well as international regulations for medical devices.
Minimum one (1) year of manufacturing experience preferred.
Possess expertise in one or more engineering fields, including mechanical, electrical, materials, bioengineering, and other relevant fields.
Proficient in designing and developing products, hardware, software, and methodologies.
Experienced in supporting medical device development through various advanced engineering and analytical approaches, including mechanical, materials, electromechanical, hardware and software development, sensing technology, artificial intelligence, machine learning, etc.
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