Mechanical Engineering - Manager

RequisitionID:          57754 Title: Manager - Mechanical Engineering Division: [[Arthrex, Inc. (US01)]] Location: Santa Barbara, CA  Salary Range: Salary Minimum: [[$143,750.00]] Salary Maximum [[$258,750.00]]

 

 

 

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The Manager – Mechanical Engineering is 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 mechanical design of Class 1 and Class 2 medical devices through entire product development lifecycle maintaining a focus on timeline and budget conformance.
• Interview, hire, train, and supervise the daily activities of assigned direct reports. Assign resources, monitor workloads, conduct performance assessments, and oversee employee development.
• Strong understanding of QMS and associated regulations relevant to Class 1 and Class 2 medical devices preferred including all DHF deliverables.
• Focus on product Quality and driving the use of the QMS systems in support of product quality (e.g., design controls, risk management, DFMEA)
• Continuous optimization of engineering throughput using lean and agile techniques.
• Continuous improvement of engineering systems (e.g., CAD, PDM, DFx, simulation, rapid prototyping) in support of rapid product development.
• Keen business perspective to enable dynamic prioritization and delegation of projects, tasks, collaborations to optimize time-to-market.
• Seen as a technical leader internally with a strong sense of internal customers (DFx) to facilitate deployment of new product designs and design changes.
• Manage both internal resources and contractors as necessary.
• Primary contributor to product planning using Lean tools, assess completeness of critical chains, manage compression activities, and reconcile based on resource loading.
• Responsible for product budget estimates as appropriate.
• Provides expert consultation in one or more areas of design, development, and implementation of technical products or systems.
• Recommends alterations to development and design to improve quality of products and/or procedures.
• 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 necessity of testing and initiates testing of assigned products
• Some required travel to attend vendors, trade shows and visit established accounts as well as prospective accounts. International travel may be required.

 

 

Education and Experience:

• Bachelor of Science Degree in Mechanical Engineering required, advanced degree preferred.
• 8 years of relevant new product development experience required. Medical device experience preferred.
• 3 years of direct management or supervision of technical teams required.
• Formal engineering management training preferred.

 

 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Expert in Capital Equipment productization and evolution within QMS and in manufacturing environment. Medical device experience preferred.
• Strong leader, clear communicator, and highly organized project manager using lean techniques:  critical chain project management, information theory, risk management.
• Deep understanding of mechanical design principals.  Optical design experience a plus.
• Expert in designing products using 3D CAD, associated design tools (tolerance analysis, thermal analysis, stress analysis, etc.), and PDM.
• Demonstrable expertise in design for manufacturability and design for cost. 
• Strong understanding of FDA and ISO guidelines for the development of medical devices preferred.
• 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.
• Knowledge of orthopedic surgery principles, theories, and products.
• Historical perspective on orthopedic surgery principals, theories, and products.