MAIN PURPOSE OF THE ROLE
Use multidisciplinary engineering knowledge to contribute to a team designing and developing innovative medical devices or components/subsystems in support of company's strategic plan.
MAIN RESPONSIBILITIES
• Design sub-assemblies to meet broad design goals, establish requirements and specification
• Use empirical, numerical and experimental analysis to analyze designs.
• Involved in test method and model development
• Identify and mitigate sub-assembly risks
• Support invention disclosures
• Work with internal departments and external vendors to obtain prototype parts and to understand their capabilities and limitations
• Support pre-clinical and clinical testing of devices
• Support design reviews and physician visits.
• Gain a detailed understanding of the developing clinical environment (i.e. current treatment methods, evolving clinical needs etc.).
• Gain a detailed understanding of the quality and regulatory requirements of SJM, FDA and ISO regulations, manage project within these requirements
• Gain a detailed understanding of overall schedule, manage time and task within schedule
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
QUALIFICATIONS
Education
Education Level
Major/Field of Study
or
Equivalent
Bachelors Degree (± 16 years)
Mechanical Engineering OR an equivalent combination of education and work experience
Experience/Background
Minimum 3 years
Experience designing and testing relevant medical devices preferred. Experience with a wide variety of manufacturing processes and DFM preferred.
Solidworks or other CAD experience required. Analytical design, Design for Six Sigma, or similar tool set preferred.
Ability to work within a team and as an individual contributor in a fast paced changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in a timely manner. Strong organizational and follow-up skills, as well as an attention to detail. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel including internationally.
The base pay for this position is
$81,500.00 – $141,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Product Development
DIVISION:CRM Cardiac Rhythm Management
LOCATION:United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:Yes, 10 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Work in a clean room environment
