Platform:
DJO
Job Description:
At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence — with the goal of transforming medical technology as we know it.
Because that’s how we change the lives of patients for the better. And that’s how we create better together.
As a key member of the Enabling Technologies Team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.
Job Title:
Manager, Base Business - Enabling Technologies
Reports To:
Director, R&D Product Development
Location:
Austin, TX
Business Unit Description:
Enabling Technologies
Job Title/High Level Position Summary: The Manager, Base Business directs the sustaining engineering activities for the Enabling Technologies business unit. In addition to managing product development resources, the Manager individually contributes to development efforts. This includes but is not limited to creating prototypes, testing, and documenting test results; scheduling, coordinating, and managing multiple projects; and communicating with vendors to ensure proper design transfer. The Manager will be responsible for products including mechanical surgical instrumentation, electronic hardware, and software used by electronic hardware.
Key Responsibilities:
- Manage project prioritization and resource allocation
- Mentor direct reports by providing technical guidance, coaching, performance management, and professional development opportunities
- Participate in product development including concept, generation, decision matrices, prototype, manufacture, and associated metrics
- Provide expert product leadership for the development projects assigned; this includes an unrelenting attention to minimizing project delays and resource overages
- Creates product designs and documentation used to substantiate those devices (i.e. risk assessments, verification/validation activities, design review documentation, etc.)
- Develops detailed engineering drawings using 3-D Modeling to document designs and design changes (SolidWorks)
- Confers with cross-functional team to identify tasks and requirements (Product Development, Manufacturing Engineers, Quality Engineers, Marketing, Purchasing and Regulatory Affairs)
- Maintains all documentation necessary for a Design History File (DHF), including Design Input Documents, Design Validation Plans/Reports, Test Protocols/Reports, and Design Input/Output Matrix.
- Assist in the regulatory submission process(FDA 510k, EU MDR, TGA, PMDA) by providing official information for regulatory review
Minimum Basic Qualifications:
- Bachelor's degree in an engineering discipline
- 8+ years of professional experience (6+ years with a Masters degree)
- Experience in medical device product development
- Experience with enabling technology (pre operative planning, navigation, robotics) preferred.
- Familiarity with software development processes
- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Must be experienced in MS Word, Excel and Project.
- Experience with 3D CAD packages (SolidWorks preferred)
- Working knowledge and requirements of ISO 13485 and 21CFR820.
Travel Requirements:
Desired Characteristics:
- Previous experience managing engineers
- Previous experience developing orthopedic medical devices(either implant development or enabling technology used with orthopedic implants)
- Previous experience leading projects of moderate to large scope and complexity
Work Environment:
- While performing the duties of this job, the employee is exposed to the manufacturing environment.
- While performing the duties of this job, the employee is exposed to the office environment.
- Employee is expected to work in varying environments, including office setting, mechanical testing lab, and cadaver lab.
- The noise level in the work environment is usually moderate.
Physical Demands:
- While performing the duties of this job, the employee is regularly required to sit, talk and hear.
- The employee frequently is required to sit and use hands to operate computer keyboard, and telephone.
- The employee is frequently required to stand, walk, and reach with hands and arms.
- This position works in a typical office/manufacturing/warehouse environment.
- The employee must occasionally lift and/or move up to 30 pounds.
- Perform job duties for 8 or more hours a day.
