Looking for a long-term contractor (12+months). This person will work collaboratively to process Engineering Change Requests, to update Drawing Prints to revise for new Regulatory requirements. This individual will support cross functional teams responsible for concept generation design and development and transfer to manufacturing of disposable and reusable medical devices. These cross functional teams will include personnel from various groups within the organization including external design and development partners suppliers and contract manufacturers.
location: Memphis, Tennessee
job type: Contract
salary: $35 - 38 per hour
work hours: 8am to 4pm
Support New Product Development Program Managers on cross functional product development teams constructing/integrating/maintaining schedules and managing design control deliverables. Ensure that the product development process abides to the business engineering quality procedures phased review discipline and regulatory needs of the applicable markets. Write and execute test plans and protocols conduct design verification and validation testing analyze results and write final reports.
This role will not have direct budget responsibilities Supervision This role will not have direct supervisory responsibly. The ability to influence and lead small projects will be required Internal and External Relationships. Effective at establishing productive relationships across the organization Ability to develop and foster strong relationships with suppliers design partners contract manufactures and clinicians
PLACE IN ORGANIZATION:
This position reports directly to a Program Manager/NPD Management within New Product Development for The Advanced Wound Device Strategic Business Unit.
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION & EXPERIENCE REQUIREMENTS
- BS in Engineering or related field with a minimum of 2 years of experience in new product development within a medical device company.
- Prior manufacturing experience desired.
- Design for Six Sigma Certification a plus.
- Knowledge of FDA and CE requirements for medical devices. GMP and ISO training.
CRITICAL SKILLS REQUIRED:
- strong planning and organizational skills.
- Excellent written verbal and presentation skills.
- Ability to recognize problems and take corrective measures.
- Ability to independently work with external technical professionals
- Experience with Microsoft Office Suite Word PowerPoint Excel Project required.
- Expertise with Computer Aided Design program required.
- Experience with Unigraphics preferred.
- Experience level: Experienced
- Minimum 2 years of experience
- Education: Bachelors
- CAD (3 years of experience is preferred)
- product development (2 years of experience is preferred)
- Medical Device (2 years of experience is preferred)
- Change Requests (2 years of experience is preferred)
- Unigraphics (2 years of experience is preferred)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.