Sr Staff Mechanical Engineer, Development - Globus Medical, Inc.
San Diego, CA
About the Job
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
Primary Responsibilities
+ Leads project teams from concept to commercialization, coordinating and managing timelines
+ Creates advanced mechanical designs using CAD and/or SolidWorks software or in-house rapid prototyping equipment suitable for traditional, novel, and additive manufacturing methods while applying design for manufacturing principles
+ Coordinates with vendors and procurement teams to manage the production and commercialization process, and drives the cost optimization
+ Creates and maintains documentation relevant to design control and other applicable regulatory requirements
+ Works with surgeons and OR staff to understand user needs
+ Creates and maintains requirements, design specifications, Risk Management & FMEAs
+ Participates in weekly core team meetings as ME lead and provides status updates
+ Participates in project planning, design and phase review, as well as audits and assists with mechanical designs and design history file documentation creation and approval
+ Oversees manufacturing partners to ensure complete, accurate and timely delivery of clinical product
+ Leads or supports cadaver labs during surgeon design team evaluations and surgeon education events, including cadaver setup, running a fluoroscopy machine, clean-up, etc.
+ Maintains active project schedules and delegates relevant project tasks to interdepartmental and cross functional team members
+ Performs other duties as assigned
Required Skills / Capabilities
+ Proficiency with CAD and SolidWorks software (Pro/E, Creo, or SolidWorks), and Microsoft Office with a strong ability to write technical reports, business reports, and correspondence
+ Proficiency and knowledge in applying concepts of algebra, geometry, trigonometry, calculus, geometric tolerances, and tolerance analysis in addition to ability to solve and interpret problems, collect data, establish facts, and draw valid conclusions
+ Ability to read and interpret documents such as drawings, safety rules, company policy and procedure manuals
+ Strong understanding of manufacturing processes and design for manufacturing
+ Strong ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstracts and/or concrete variables
+ Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13585 & IEC 60601
Education and Experience
+ Typically requires a minimum of 10 years of related experience with a Bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 5 years’ experience; or equivalent experience
+ Bachelor's or advanced degree in Mechanical Engineering, Biomedical Engineering, or related technical discipline
+ Experience with Geometric Dimensioning & Tolerance
+ Previous medical device experience; spine or orthopedics preferred
Our Values :
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
+ Passionate about Innovation : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
+ Customer Focused : We listen to our customers’ needs and respond with a sense of urgency.
+ Teamwork : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
+ Driven : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Equal Employment Opportunity :
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.
Other Duties :
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Primary Responsibilities
+ Leads project teams from concept to commercialization, coordinating and managing timelines
+ Creates advanced mechanical designs using CAD and/or SolidWorks software or in-house rapid prototyping equipment suitable for traditional, novel, and additive manufacturing methods while applying design for manufacturing principles
+ Coordinates with vendors and procurement teams to manage the production and commercialization process, and drives the cost optimization
+ Creates and maintains documentation relevant to design control and other applicable regulatory requirements
+ Works with surgeons and OR staff to understand user needs
+ Creates and maintains requirements, design specifications, Risk Management & FMEAs
+ Participates in weekly core team meetings as ME lead and provides status updates
+ Participates in project planning, design and phase review, as well as audits and assists with mechanical designs and design history file documentation creation and approval
+ Oversees manufacturing partners to ensure complete, accurate and timely delivery of clinical product
+ Leads or supports cadaver labs during surgeon design team evaluations and surgeon education events, including cadaver setup, running a fluoroscopy machine, clean-up, etc.
+ Maintains active project schedules and delegates relevant project tasks to interdepartmental and cross functional team members
+ Performs other duties as assigned
Required Skills / Capabilities
+ Proficiency with CAD and SolidWorks software (Pro/E, Creo, or SolidWorks), and Microsoft Office with a strong ability to write technical reports, business reports, and correspondence
+ Proficiency and knowledge in applying concepts of algebra, geometry, trigonometry, calculus, geometric tolerances, and tolerance analysis in addition to ability to solve and interpret problems, collect data, establish facts, and draw valid conclusions
+ Ability to read and interpret documents such as drawings, safety rules, company policy and procedure manuals
+ Strong understanding of manufacturing processes and design for manufacturing
+ Strong ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstracts and/or concrete variables
+ Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13585 & IEC 60601
Education and Experience
+ Typically requires a minimum of 10 years of related experience with a Bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 5 years’ experience; or equivalent experience
+ Bachelor's or advanced degree in Mechanical Engineering, Biomedical Engineering, or related technical discipline
+ Experience with Geometric Dimensioning & Tolerance
+ Previous medical device experience; spine or orthopedics preferred
Our Values :
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
+ Passionate about Innovation : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
+ Customer Focused : We listen to our customers’ needs and respond with a sense of urgency.
+ Teamwork : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
+ Driven : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Equal Employment Opportunity :
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.
Other Duties :
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Source : Globus Medical, Inc.