Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Electrical Engineering Manager that will be Responsible for full life cycle development of ACT product, which includes initiation, design, development, execution, and product maintenance. Recognized as technical leader and resource. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Essential Duties and Responsibilities:
Team leader in support of electrical product architecture, critical component selection and design of Class 1 and Class 2 medical devices through entire product development lifecycle, including maintenance and obsolescence, maintaining a focus on timeline and budget conformance.
Focus on product Quality and driving the use of the QMS systems in support of product quality (e.g. design controls, risk management, DFMEA)
Strong team leader with keen business perspective to enable dynamic prioritization and delegation of projects, tasks, collaborations to optimize time-to-market.
Continuous improvement of engineering tools and processes (e.g. CAD, PDM, Rapid Prototyping) in support of rapid product development.
Seen as a technical leader internally with a strong sense of internal customers to facilitate deployment of new product designs and design changes.
Manage both internal resources and contractors as necessary.
Responsible for accuracy and completeness of product budget and timeline estimates as appropriate.
Provides expert consultation in one or more areas of design, development, and implementation of technical products or systems.
Provides Regulatory department technical support for assigned projects as needed.
Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products.
Supports Manufacturing to provide processing improvements.
Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed.
Determines requirements and acceptance criteria for system and sub-system testing.
Provides input and direction to other members of the engineering staff to assist them in their assignments and provide them with learning experience.
Some required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.
Education and Experience:
Bachelor of Science Degree in Engineering or equivalent work experience required; MS preferred.
10 years of relevant experience is required, a minimum of 3 years in a management capacity. Medical device experience preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Expert in Medical Capital Equipment productization and evolution within QMS and in manufacturing environment including working knowledge of relevant standards (e.g. IEC 60601-1).
Strong leader, clear communicator, and highly organized project manager using lean techniques: critical chain project management, information theory, risk management.
Demonstratable experience in successfully managing Electrical engineers working effectively in cross functional teams.
Proficient knowledge of high speed digital and alalog electronic design principals including specifying hardware and firmware solutions to meet product requirements; video design experience preferred.
Proficient in designing products using schematic capture and layout tools. Altium experience preferred.
Demonstrable expertise in design for manufacturability, design for cost, design for test.
Strong understanding of FDA and ISO guidelines for the development of medical devices required.
Demonstrable experience in design for reliability.
Excellent troubleshooting skills and experience with root cause analysis techniques
Technical knowledge in development methodologies, design, and project implementation.
Experience with Medical Equipment development and testing.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
