Development Engineer III

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Job description

SUMMARY
!!!! Candidates MUST be within the Austin TX vicinity. However, this could be a "hybrid" work model: part time working from home, part time at the Austin facility.
CANDIDATES MUST HAVE PRIOR MEDICAL DEVICE EXPERIENCE AND/OR ORTHOPAEDIC DEVICE EXPERIENCE. The manager will NOT accept anyone without this experience. !!!!
TEMP TO FULL TIME OPPORTUNITY FOR RIGHT WORKER

Reporting to a member of the Product Support management team this person will work collaboratively to construct schedule & execute integrated project plans ensure that the necessary resources are applied and delivering to plan perform engineering development actives coordinate and participate in verification and validation testing analyze data and author reports. 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.Essential Duties & Responsibilities
? Support 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 analyse results and write final reports.
? Perform engineering tasks as assigned.
? Communicate deliverable progress risks and opportunities to Product Support Leadership Team.

SCOPE OF POSITION RESPONSIBILITIES Financial (Funds Costs Profits) ? 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 the Engineering Manager within Product Support for the Trauma and Extremities Unit in Austin, TX.

QUALIFICATION REQUIREMENTS
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 3 years of experience in product development within a medical device company
? Prior manufacturing experience desired
? 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

COMPUTER SKILLS
? Experience with Microsoft Office Suite Word PowerPoint Excel Project required
? Basic understanding and experience with Solid Works/CAD
? Experience working with statistical software a plus.

PHYSICAL DEMANDS
? The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.